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1. Percutaneous endoscopic gastrostomy, body weight loss and survival in amyotrophic lateral sclerosis: a population-based registry study

Author

Fasano, Antonio, Fini, Nicola, Ferraro, Diana, Ferri, Laura, Vinceti, Marco, Mandrioli, Jessica, Mandrioli, J., Fini, N., Fasano, A., Nichelli, P., Biguzzi, S., Handouk, Y., Venturini, E., Passarin, M. G., Guidi, C., Neri, W., Sette, E., Tugnoli, V., Tola, M. R., Terlizzi, E., Guidetti, D., Currò Dossi, M., Pasquinelli, M., Andruccioli, J., Ravasio, A., Casmiro, M., Rasi, F., Salvi, F., Bartolomei, I., Michelucci, R., Avoni, P., De Pasqua, S., Liguori, R., Rizzi, R., Canali, E., Marcello, N., Taga, A., Zinno, L., Pietrini, V., Aiello, M., Medici, D., Chierici, E., Montanari, E., Santangelo, M., Amidei, S., Casetta, Ilaria, Groppo, E., Granieri, Enrico Gavino Giuseppe, De Massis, P., Mussuto, V., Borghi, A., Gabellini, A., Sacquegna, T., Rinaldi, R., Cirignotta, F., Ferro, S., and D'Alessandro, R.

Subjects
Male, medicine.medical_specialty, Neurology, medicine.medical_treatment, Population, Amyotrophic lateral sclerosis, body weight loss, percutaneous endoscopic gastrostomy, population-based study, survival, Neurology (clinical), macromolecular substances, Enteral administration, Endoscopy, Gastrointestinal, Amyotrophic lateral sclerosis, percutaneous endoscopic gastrostomy, body weight loss, survival, population-based study, Body Mass Index, NO, Cohort Studies, 03 medical and health sciences, Enteral Nutrition, Tracheostomy, 0302 clinical medicine, Percutaneous endoscopic gastrostomy, Weight Loss, PEG ratio, medicine, Humans, Registries, 030212 general & internal medicine, education, Aged, Gastrostomy, education.field_of_study, business.industry, Middle Aged, medicine.disease, Survival Analysis, Surgery, Treatment Outcome, Italy, Cohort, Female, Observational study, Deglutition Disorders, business, 030217 neurology & neurosurgery
Abstract

To assess the role of percutaneous endoscopic gastrostomy (PEG) insertion, and its timing, on ALS survival, and to study prognostic factors of survival before and after PEG placement in a population-based setting.In this observational population-based, registry study, we enrolled patients with newly- diagnosed ALS, according to the El Escorial revised criteria, who were resident in the Emilia Romagna Region, and who developed severe dysphagia needing enteral nutritional support. The primary outcome measure was tracheostomy-free survival after PEG recommendation.There were 210 patients needing PEG, out of an incident cohort of 545 patients from the Emilia Romagna Registry for ALS, who were diagnosed between 2009 and 2013. One hundred and ninety-three patients were included in the study, and 17 were excluded because they were already tracheostomized at the time of PEG placement. Of the 193 patients included in the study, 152 underwent PEG, whereas 41 did not undergo the procedure. Patients who did not undergo PEG, among the eligible ones, had the same tracheostomy-free survival from onset as patients who did (25 vs. 32 months, p = 0.21). Tracheostomy-free survival from PEG recommendation was greater in patients who underwent PEG placement than in patients who did not (6 vs. 2 months, p = 0.008). Median tracheostomy-free survival from PEG insertion was eight months (95% CI5-12); 30 days after PEG placement, survival was 89.60%. At Cox multivariable analysis, the hazard of death or tracheostomy after PEG insertion was significantly influenced by the difference between BMI at the time of the PEG procedure and BMI at diagnosis (HR 1.05, 95% CI 1.02-1.08; p = 0.002). The hazard of death or tracheostomy was not affected by the timing of PEG insertion.The present study, although it has some limitations, suggests a gain of tracheostomy-free survival from the time of PEG recommendation for patients who undergo PEG placement, and, among patients who undergo PEG, a greater survival if PEG is inserted before a significant weight loss occurs, and if nutritional support avoids further weight loss. Should this association between prevention of weight loss and better clinical outcome be confirmed by further studies, it would have important implications for disease management.

Published
2017

2. A further Rasch study confirms that ALSFRS-R does not conform to fundamental measurement requirements

Author

Franchignoni, Franco, Mandrioli, Jessica, Giordano, Andrea, Ferro, Salvatore, Mandrioli, J., Fini, N., Georgoulopoulou, E., Nichelli, P., Biguzzi, S., Venturini, E., Passarin, M. G., Guidi, C., Neri, W., Sette, E., Tugnoli, V., Tola, M. R., Terlizzi, E., Guidetti, D., Curro Dossi, M., Pasquinelli, M., Andruccioli, J., Ravasio, A., Casmiro, M., Rasi, F., Salvi, F., Bartolomei, I., Michelucci, R., Avoni, P., De Pasqua, S., Liguori, R., Rizzi, R., Canali, E., Marcello, N., Grassi, A., Delay, L., Pietrini, V., Aiello, M., Chierici, E., Montanari, E., Santangelo, M., Amidei, S., Greco, G., Casetta, I., Groppo, E., Granieri, E., De Massis, P., Mussuto, V., Borghi, A., Gabellini, A., Sacquegna, T., Rinaldi, R., Cirignotta, F., Ferro, S., D'Alessandro, R., Franchignoni, Franco, Mandrioli, Jessica, Giordano, Andrea, Ferro, Salvatore, Mandrioli, J., Fini, N., Georgoulopoulou, E., Nichelli, P., Biguzzi, S., Venturini, E., Passarin, M.G., Guidi, C., Neri, W., Sette, E., Tugnoli, V., Tola, M.R., Terlizzi, E., Guidetti, D., Curro Dossi, M., Pasquinelli, M., Andruccioli, J., Ravasio, A., Casmiro, M., Rasi, F., Salvi, F., Bartolomei, I., Michelucci, R., Avoni, P., De Pasqua, S., Liguori, R., Rizzi, R., Canali, E., Marcello, N., Grassi, A., Delay, L., Pietrini, V., Aiello, M., Chierici, E., Montanari, E., Santangelo, M., Amidei, S., Greco, G., Casetta, I., Groppo, E., Granieri, E., De Massis, P., Mussuto, V., Borghi, A., Gabellini, A., Sacquegna, T., Rinaldi, R., Cirignotta, F., Ferro, S., and D'Alessandro, R.

Subjects
Rasch analysi, Adult, Male, medicine.medical_specialty, Psychometrics, Community Health Planning, Retrospective Studie, ALSFRS-R, medicine, Humans, Respiratory function, Amyotrophic lateral sclerosis, Amyotrophic lateral sclerosi, population based study, Aged, Retrospective Studies, Rasch model, Alsfrs r, Amyotrophic Lateral Sclerosis, Rasch analysis, Retrospective cohort study, Middle Aged, medicine.disease, Differential item functioning, Confirmatory factor analysis, Neurology, Physical therapy, Female, Neurology (clinical), Factor Analysis, Statistical, Psychology, Psychometric, Human
Abstract

Our objective was to verify and expand previous evidence of psychometric inadequacies in the ALSFRS-R, in a different sample of subjects suffering from ALS. Since 2009, a prospective registry records all incident cases of ALS in Emilia Romagna Region, Italy (4.4 million inhabitants) referred to its 17 neurological departments. For each patient, demographic and clinical information is collected by the physician in charge, including compilation of the ALSFRS-R at each clinical follow-up. Results showed that a confirmatory factor analysis on the three-factor model previously found (bulbar, motor, respiratory function) showed a good fit. Rasch analysis on the whole scale showed the need to collapse some rating categories, confirmed the multidimensionality of the ALSFRS-R, and demonstrated the presence of differential item functioning between patients with spinal versus bulbar onset. Moreover, some items included in the three ALSFRS-R subscales showed a problematic fit to the respective construct they were intended to measure. In conclusion, the interpretation of a total raw score of ALSFRS-R is hampered by ambiguities due to the different metric properties of the three domains the scale aggregates, and their content and structure. This study confirms that a refinement of ALSFRS-R is warranted, pointing to the need to revise its whole structure, and providing detailed guidelines for its revision.

Published
2015

3. Incidence of neuroepithelial primary brain tumors among adult population of Emilia-Romagna Region, Italy

Author

Baldin, Elisa, Testoni, Stefania, de Pasqua, Silvia, Ferro, Salvatore, Albani, Fiorenzo, Baruzzi, Agostino, D’alessandro, Roberto, On behalf of PERNO study group, Null, Baruzzi, A., Albani, F., Calbucci, F., D’alessandro, R., Michelucci, R., Brandes, A., Eusebi, V., Ceruti, Stefano, Fainardi, Enrico, Tamarozzi, R., Emiliani, E., Cavallo, Michele Alessandro, Franceschi, E., Tosoni, A., Cavallo, M., Fiorica, F., Valentini, A., Depenni, R., Mucciarini, C., Crisi, G., Sasso, E., Biasini, C., Cavanna, L., Guidetti, D., Marcello, N., Pisanello, A., Cremonini, A. M., Guiducci, G., de Pasqua, S., Testoni, S., Agati, R., Ambrosetto, G., Bacci, A., Baldin, E., Baldrati, A., Barbieri, E., Bartolini, S., Bellavista, E., Bisulli, F., Bonora, E., Bunkheila, F., Carelli, V., Crisci, M., Dall’occa, P., Ferro, S., Franceschi, C., Frezza, G., Grasso, V., Leonardi, M., Mostacci, B., Palandri, G., Pasini, E., Pastore Trossello, M., Poggi, R., Riguzzi, P., Rinaldi, R., Rizzi, S., Romeo, G., Spagnolli, F., Tinuper, P., Trocino, C., Dall’agata, M., Faedi, M., Frattarelli, M., Gentili, G., Giovannini, A., Iorio, P., Pasquini, U., Galletti, G., Guidi, C., Neri, W., Patuelli, A., Strumia, S., Casmiro, M., Gamboni, A., Rasi, F., Cruciani, G., Cenni, P., Dazzi, C., Guidi, A. R., Zumaglini, F., Amadori, A., Pasini, G., Pasquinelli, M., Pasquini, E., Polselli, A., Ravasio, A., Viti, B., Sintini, M., Ariatti, A., Bertolini, F., Bigliardi, G., Carpeggiani, P., Cavalleri, F., Meletti, S., Nichelli, P., Pettorelli, E., Pinna, G., Zunarelli, E., Artioli, F., Bernardini, I., Costa, M., Greco, G., Guerzoni, R., Stucchi, C., Iaccarino, C., Ragazzi, M., Rizzi, R., Zuccoli, G., Api, P., Cartei, F., Fallica, Elisa, Granieri, Enrico Gavino Giuseppe, Latini, Francesco, Lelli, G., Monetti, C., Saletti, A., Schivalocchi, Roberta, Seraceni, S., Tola, Maria Rosaria, Urbini, B., Giorgi, C., Montanari, E., Cerasti, D., Crafa, P., Dascola, I., Florindo, I., Giombelli, E., Mazza, S., Ramponi, Vania, Servadei, F., Silini, E. M., Torelli, P., Immovilli, P., Morelli, N., Vanzo, C., Nobile, C., Baldin, Elisa, Testoni, Stefania, De Pasqua, Silvia, Ferro, Salvatore, Albani, Fiorenzo, Baruzzi, Agostino, D'Alessandro, Roberto, On behalf of PERNO study group, Baruzzi, A., Albani, F., Calbucci, F., D'Alessandro, R., Michelucci, R., Brandes, A., Eusebi, V., Ceruti, S., Fainardi, E., Tamarozzi, R., Emiliani, E., Cavallo, M., Franceschi, E., Tosoni, A., Fiorica, F., Valentini, A., Depenni, R., Mucciarini, C., Crisi, G., Sasso, E., Biasini, C., Cavanna, L., Guidetti, D., Marcello, N., Pisanello, A., Cremonini, A. M., Guiducci, G., de Pasqua, S., Testoni, S., Agati, R., Ambrosetto, G., Bacci, A., Baldin, E., Baldrati, A., Barbieri, E., Bartolini, S., Bellavista, E., Bisulli, F., Bonora, E., Bunkheila, F., Carelli, V., Crisci, M., Dall'Occa, P., Ferro, S., Franceschi, C., Frezza, G., Grasso, V., Leonardi, M., Mostacci, B., Palandri, G., Pasini, E., Pastore Trossello, M., Poggi, R., Riguzzi, P., Rinaldi, R., Rizzi, S., Romeo, G., Spagnolli, F., Tinuper, P., Trocino, C., Dall'Agata, M., Faedi, M., Frattarelli, M., Gentili, G., Giovannini, A., Iorio, P., Pasquini, U., Galletti, G., Guidi, C., Neri, W., Patuelli, A., Strumia, S., Casmiro, M., Gamboni, A., Rasi, F., Cruciani, G., Cenni, P., Dazzi, C., Guidi, A. R., Zumaglini, F., Amadori, A., Pasini, G., Pasquinelli, M., Pasquini, E., Polselli, A., Ravasio, A., Viti, B., Sintini, M., Ariatti, A., Bertolini, F., Bigliardi, G., Carpeggiani, P., Cavalleri, F., Meletti, S., Nichelli, P., Pettorelli, E., Pinna, G., Zunarelli, E., Artioli, F., Bernardini, I., Costa, M., Greco, G., Guerzoni, R., Stucchi, C., Iaccarino, C., Ragazzi, M., Rizzi, R., Zuccoli, G., Api, P., Cartei, F., Fallica, E., Granieri, E., Latini, F., Lelli, G., Monetti, C., Saletti, A., Schivalocchi, R., Seraceni, S., Tola, M. R., Urbini, B., Giorgi, C., Montanari, E., Cerasti, D., Crafa, P., Dascola, I., Florindo, I., Giombelli, E., Mazza, S., Ramponi, V., Servadei, F., Silini, E. M., Torelli, P., Immovilli, P., Morelli, N., Vanzo, C., and Nobile, C.

Subjects
Registrie, Male, Pediatrics, Neurology, Survival, Epidemiology, medicine.medical_treatment, Primary brain tumors, 0302 clinical medicine, Neoplasms, 80 and over, Medicine, Oligodendroglial Tumor, Registries, Neuroradiology, Aged, 80 and over, education.field_of_study, Brain Neoplasms, Incidence (epidemiology), Incidence, General Medicine, Middle Aged, Neoplasms, Neuroepithelial, Glioblastoma, Incidence rate, Adult, Aged, Female, Humans, Italy, 2708, Neurology (clinical), Psychiatry and Mental Health, 030220 oncology & carcinogenesis, Neurosurgery, Human, medicine.medical_specialty, Population, Neuroepithelial, Dermatology, Primary brain tumor, NO, Brain Neoplasm, 03 medical and health sciences, education, business.industry, Radiation therapy, business, 030217 neurology & neurosurgery
Abstract

Incidence of neuroepithelial Primary Brain Tumors (nPBT) varies, ranging from 7.3 to 11.6 cases/100,000/year across Europe. We present incidence and survival of nPBT in the Emilia-Romagna region (ER), Italy. This study is the largest in Southern Europe. Specialists in neurosurgery, neurology, neuroradiology, oncology, radiotherapy, genetics, and pathology of ER notified all suspected nPBT adult cases residing in ER (4,337,966 inhabitants) observed during 2009. Furthermore, through ICD-9 discharge codes, we identified and reviewed all possible cases. Neuroepithelial PBT diagnosis was based on histological or radiological findings. We included 400 incident nPBT cases, of which 102 (25%) were retrospectively identified. These latter were significantly older. The standardized incidence was 10.5/100,000/year (95% CI 9.4–11.5), higher for men. It was 9.2/100,000/year (95% CI 8.3–10.2) for astrocytic tumors, 0.6/100,000/year (95% CI 0.4–0.9) for oligodendroglial tumors, and 7.1 (95% CI 6.3–8.0) for glioblastoma (GBM). Among GBM patients, median survival was 249 days if prospectively identified vs. 132 days when identified through ICD-9 codes (pÂ

Published
2017

4. Stroke units in Italy: engaging the public in optimizing existing resources

Author

Baldereschi, M, Di Carlo, A., Vaccaro, C., Toni, Danilo, Polizzi, B., Inzitari, D., Baldereschi, M., Candelise, L., Consoli, D., Carlo, Di, Fieschi, Cesare, Guidetti, D., Provinciali, L., Rasura, Maurizia, Sacchetti, Maria Luisa, Silvestrini, M., and Toni, D.

Subjects
Questionnaires, Adult, Male, Gerontology, Multivariate analysis, Acute stroke care, Stroke as emergency, Stroke awareness, Stroke education, Stroke resource use, Stroke units, Adolescent, Age Distribution, Aged, Female, Hospital Units, Humans, Italy, Middle Aged, Odds Ratio, Prevalence, Stroke, Tissue Plasminogen Activator, Young Adult, Awareness, Neurology (clinical), Neurology, Medicine (all), Sample (statistics), Affect (psychology), Surveys and Questionnaires, medicine, Young adult, business.industry, Odds ratio, medicine.disease, Resource use, Medical emergency, business
Abstract

Background and purpose The lack of a wide implementation of stroke units (SU)s in Italy appears to accompany the underuse of the operating units. Community awareness of acute stroke care options may affect stroke resource use. Our aim was to determine the level of knowledge about SUs and tissue-plasminogen activator (t-PA) treatment amongst Italian adults and investigate its relationship to local stroke services implementation. Methods A nation-based telephone survey was carried out in a sample of 1000 residents aged >18 years in May–June 2010. The questionnaire included close-ended questions regarding knowledge of SUs and t-PA treatment. Number and location of both SUs and t-PA treatments were provided by a concurrent national hospital-based survey. The prevalence and distribution of acute stroke care awareness in the community was examined and multivariate analyses were generated. Results Amongst the 1000 participants (474 men, mean age 48.8 ± 17.2), only 26.2% reported knowing about the availability of t-PA treatment and only 15% were aware of the existence of SUs. Awareness of both SUs and t-PA was significantly associated only with education. These associations remained significant in the multivariate analyses. The degree of stroke services implementation (in terms of SUs/inhabitant rates and number of t-PA treatments) was not associated with SU and t-PA awareness. Conclusions This is the first European study that explored public knowledge about t-PA treatment and SUs. Italian adults proved insufficiently educated about SUs and t-PA; there is no higher awareness in areas with a greater supply of stroke services. This might partially explain the underuse of Italian SUs.

Published
2014

5. A Multicentric Prospective Incidence Study of Guillain-Barré Syndrome in Italy. The ITANG Study

Author

Benedetti, M, Pugliatti, M, Dalessandro, R, BEGHI, ETTORE, Chiò, A, Logroscino, G, Filippini, G, Galeotti, F, Massari, M, Santuccio, C, Raschetti, R, Abruzzi, L, Agazzi, E, Agostoni, E, Ambrogio, L, Amidei, S, Arbasino, C, Argentiero, V, Arnaboldi, M, Baldini, D, Barki, R, Bassi, P, Basso, F, Belcastro, V, Bellotti, M, Bersano, E, Besana, R, Bettoni, L, Bezzi, G, Bianconi, C, Bondavalli, M, Bonometti, A, Borghi, AM, Borsato, C, Bortolotto, S, Bottacchi, EF, Bresolin, N, Bruno, S, Burlina, A, Cafasso, G, Callegarini, C, Calvo, A, Candeloro, E, Casano, A, Cattaneo, SI, Cavallo, R, Cheldi, A, Ciardo, G, Cirignotta, F, Clerici, AM, Clerici, R, Comi, G, Conti, R, Coppo, F, Covelli, V, Crespi, V, Currò Dossi, M, Curtò, NA, D'Adda, E, Dallocchio, C, D'Anna, S, De Massis, P, De Toni Franceschini, L, Di Vito, N, Didonè, G, Dileone, M, Donati, E, Dotta, M, Fazio, R, Federico, F, FERRARESE, CARLO, Ferrazzini, F, Ferrero, B, Filosto, M, Frasson, E, Fusina, S, Galbussera, A, Gastaldo, E, Geda, C, Ghiglione, P, Giometto, B, Gionco, M, Giorgetti, A, Giussani, G, Gobbin, F, Grampa, G, Granieri, E, Greco, G, Guidetti, D, Guidi, C, Guidotti, M, Gusmaroli, G, Imperiale, D, Internò, S, Jann, S, La Spina, I, Leo, A, Leone, M, Leoni, S, Leotta, D, Lerario, R, Liotta, G, Livrea, P, Luda di Cortemiglio, E, Maggio, B, Magni, E, Magnoni, A, Maistrelli, J, Manca, D, Mandrioli, J, Manera, U, Marcello, N, Marchi, P, Marchini, C, Marconi, S, Mattioli, M, Mauro, A, Mazzaglia, G, Medici, D, Meineri, P, Meola, G, Micaglio, G, Michelucci, R, Michieli, G, Micieli, G, Minardi, C, Moglia, C, Monaco, S, Montanari, E, Moretto, G, Munerati, V, Mura, G, Mussutto, V, Nascimbene, C, Neri, W, Nichelli, P, Nobile Orazio, E, Oddenino, E, Onorato, S, Padovani, A, Palermo, M, Papurello, DM, Passarella, B, Pavesi, G, Penza, MT, Perini, M, Perini, F, Perla, F, Perlotto, N, Perrone, P, Pignatta, P, Pisano, F, Poglio, F, Polo, A, Poloni, M, Porazzi, D, Pradotto, L, Previdi, P, Quatrale, R, Rasi, F, Ravasio, A, Ravetti, C, Repaci, M, Riccardi, T, Riguzzi, P, Rinaldi, R, Riva, M, Romeo, V, Romorini, A, Rosso, T, Rotondo, G, Sacquegna, T, Sanson, F, Santamato, V, Santoro, D, Sartori, V, Sasanelli, F, Savio, K, Serena, M, Silani, V, Silvestri, L, Simioni, V, Squintani, GM, Suardelli, M, Tartagla, L, Terenghi, F, Terlizzi, E, Terzano, M, Tesser, F, Testa, L, Ticca, A, Ticozzi, N, Tiriticco, M, Tola, MR, Tonietti, S, Trianni, G, Trojano, M, Trotta, F, Turatti, M, Ursino, E, Vanotti, A, Vercellino, M, Villani, A, Vitelli, E, Zambito Marsala, S, Zanette, G, Zarcone, D, Zimatore, G, Zoccolella, S., Benedetti, Md, Pugliatti, M, D'Alessandro, R, Beghi, E, Chiò, A, Logroscino, G, Filippini, G, Galeotti, F, Massari, M, Santuccio, C, Comi, Giancarlo, Raschetti, R, ITANG Study, Group, Giometto, B, Benedetti, M, Dalessandro, R, Abruzzi, L, Agazzi, E, Agostoni, E, Ambrogio, L, Amidei, S, Arbasino, C, Argentiero, V, Arnaboldi, M, Baldini, D, Barki, R, Bassi, P, Basso, F, Belcastro, V, Bellotti, M, Bersano, E, Besana, R, Bettoni, L, Bezzi, G, Bianconi, C, Bondavalli, M, Bonometti, A, Borghi, A, Borsato, C, Bortolotto, S, Bottacchi, E, Bresolin, N, Bruno, S, Burlina, A, Cafasso, G, Callegarini, C, Calvo, A, Candeloro, E, Casano, A, Cattaneo, S, Cavallo, R, Cheldi, A, Ciardo, G, Cirignotta, F, Clerici, A, Clerici, R, Comi, G, Conti, R, Coppo, F, Covelli, V, Crespi, V, Currò Dossi, M, Curtò, N, D'Adda, E, Dallocchio, C, D'Anna, S, De Massis, P, De Toni Franceschini, L, Di Vito, N, Didonè, G, Dileone, M, Donati, E, Dotta, M, Fazio, R, Federico, F, Ferrarese, C, Ferrazzini, F, Ferrero, B, Filosto, M, Frasson, E, Fusina, S, Galbussera, A, Gastaldo, E, Geda, C, Ghiglione, P, Gionco, M, Giorgetti, A, Giussani, G, Gobbin, F, Grampa, G, Granieri, E, Greco, G, Guidetti, D, Guidi, C, Guidotti, M, Gusmaroli, G, Imperiale, D, Internò, S, Jann, S, La Spina, I, Leo, A, Leone, M, Leoni, S, Leotta, D, Lerario, R, Liotta, G, Livrea, P, Luda di Cortemiglio, E, Maggio, B, Magni, E, Magnoni, A, Maistrelli, J, Manca, D, Mandrioli, J, Manera, U, Marcello, N, Marchi, P, Marchini, C, Marconi, S, Mattioli, M, Mauro, A, Mazzaglia, G, Medici, D, Meineri, P, Meola, G, Micaglio, G, Michelucci, R, Michieli, G, Micieli, G, Minardi, C, Moglia, C, Monaco, S, Montanari, E, Moretto, G, Munerati, V, Mura, G, Mussutto, V, Nascimbene, C, Neri, W, Nichelli, P, Nobile Orazio, E, Oddenino, E, Onorato, S, Padovani, A, Palermo, M, Papurello, D, Passarella, B, Pavesi, G, Penza, M, Perini, M, Perini, F, Perla, F, Perlotto, N, Perrone, P, Pignatta, P, Pisano, F, Poglio, F, Polo, A, Poloni, M, Porazzi, D, Pradotto, L, Previdi, P, Quatrale, R, Rasi, F, Ravasio, A, Ravetti, C, Repaci, M, Riccardi, T, Riguzzi, P, Rinaldi, R, Riva, M, Romeo, V, Romorini, A, Rosso, T, Rotondo, G, Sacquegna, T, Sanson, F, Santamato, V, Santoro, D, Sartori, V, Sasanelli, F, Savio, K, Serena, M, Silani, V, Silvestri, L, Simioni, V, Squintani, G, Suardelli, M, Tartagla, L, Terenghi, F, Terlizzi, E, Terzano, M, Tesser, F, Testa, L, Ticca, A, Ticozzi, N, Tiriticco, M, Tola, M, Tonietti, S, Trianni, G, Trojano, M, Trotta, F, Turatti, M, Ursino, E, Vanotti, A, Vercellino, M, Villani, A, Vitelli, E, Zambito Marsala, S, Zanette, G, Zarcone, D, Zimatore, G, and Zoccolella, S

Subjects
Adult, Male, Pediatrics, medicine.medical_specialty, Epidemiology, Population, Guillain-Barre Syndrome, Rate ratio, NO, Young Adult, Axonal and demyelinating GBS, Guillain-Barré syndrome, Incidence, Prospective study, Trend, Neurology (clinical), Aged, Aged, 80 and over, Female, Humans, Italy, Middle Aged, 80 and over, medicine, Young adult, education, Prospective cohort study, education.field_of_study, Guillain-Barre syndrome, business.industry, Medicine (all), Incidence (epidemiology), medicine.disease, Vaccination, Settore MED/26 - NEUROLOGIA, business, Human
Abstract

Background: To assess Guillain-Barré syndrome (GBS) incidence we relied on the Italian Network for the study of GBS (ITANG) established in 2010 in 7 Italian regions to analyse the association between influenza vaccination and GBS. Methods: All individuals aged ≥18 years, presenting with clinical manifestations that suggested GBS according to the universally accepted Asbury's diagnostic criteria (1990) were prospectively notified to a centralised database by ITANG neurologists over the period October 1, 2010-September 30, 2011. Through a telephone survey, 9 trained interviewers followed up the cases to diagnosis and then for 1 year since hospital discharge. Validation of case reporting was performed with the support of administrative data in 5 regions. Results: We found 365 cases fulfilling the definition for GBS or one of its variants over 19,846,068 population ≥18 years of age, yielding an annual incidence rate of 1.84 per 100,000 (95% CI 1.65-2.03), 2.30 (95% CI 1.99-2.60) in men and 1.41 (95% CI 1.18-1.64) in women. A highly significant peak of incidence was observed in February 2011 as compared to reference month (September 2011, rate ratio 3.3:1, p < 0.01). Conclusions: In Italy, GBS incidence was among the highest reported in Europe and higher than previously observed in Italian studies.

Published
2015

6. Serum IgG against Simian Virus 40 antigens are hampered by high levels of sHLA-G in patients affected by inflammatory neurological diseases, as multiple sclerosis

Author

Rizzo, Roberta, Pietrobon, Silvia, Mazzoni, Elisa, Bortolotti, D., Martini, Fernanda, Castellazzi, Massimiliano, Casetta, Ilaria, Fainardi, Enrico, Luca, Dario, Granieri, Enrico, Tognon, Mauro, Granieri, E., Castellazzi, M., Casetta, I., Tola, M. R., Fainardi, E., Dallocchio, F., Bellini, T., Rizzo, R., Rotola, A., Di Luca, D., Seraceni, S., Contini, C., Sabbioni, S., Negrini, M., Tognon, M., Antonelli, T., Groppo, E., Gentile, M., Baldi, E., Caniatti, M. L., Ceruti, S., Manfrinato, M. R., Trentini, A., Miotto, E., Ferracin, M., Mazzoni, E., Pietrobon, S., Masini, I., Rotondo, J. C., Martini, F., Baruzzi, A., Roberto D'Alessandro, R., Michelucci, R., Salvi, F., Stecchi, S., Scandellari, C., Terzano, G., Granella, F., Nichelli, Paolo Frigio, Sola, P., Ferraro, Diana, Vitetta, F., Simone, ANNA MARIA, Bedin, Roberta, Marcello, N., Motti, L., Montepietra, S., Guidetti, D., Immovilli, P., Montanari, E., Pesci, I., Guareschi, A., Greco, G., Santangelo, M., Mauro, A. M., Malagù, S., Rasi, F., Spadoni, M., Galeotti, M., Fiorani, L., Neri, W., Ravasio, A., Pasquinelli, M., Gutman, S., and Monaldini, C.

Subjects
0301 basic medicine, Adult, Male, viruses, HLA-G, Socio-culturale, Multiple sclerosis, SV40, Medicine (all), Biochemistry, Genetics and Molecular Biology (all), Disease, Human leukocyte antigen, Simian virus 40, Antibodies, Viral, General Biochemistry, Genetics and Molecular Biology, Immunoglobulin G, Virus, 03 medical and health sciences, 0302 clinical medicine, Antigen, Aged, Antigens, Viral, Female, HLA-G Antigens, Humans, Inflammation, Middle Aged, Multiple Sclerosis, Solubility, medicine, Medicine(all), biology, business.industry, Biochemistry, Genetics and Molecular Biology(all), Research, General Medicine, medicine.disease, 030104 developmental biology, Immunology, biology.protein, business, 030217 neurology & neurosurgery
Abstract

Background Many investigators detected the simian polyomavirus SV40 footprints in human brain tumors and neurologic diseases and recently it has been indicated that SV40 seems to be associated with multiple sclerosis (MS) disease. Interestingly, SV40 interacts with human leukocyte antigen (HLA) class I molecules for cell entry. HLA class I antigens, in particular non-classical HLA-G molecules, characterized by an immune-regulatory function, are involved in MS disease, and the levels of these molecules are modified according with the disease status. Objective We investigated in serum samples, from Italian patients affected by MS, other inflammatory diseases (OIND), non-inflammatory neurological diseases (NIND) and healthy subjects (HS), SV40-antibody and soluble sHLA-G and the association between SV40-prevalence and sHLA-G levels. Methods ELISA tests were used for SV40-antibodies detection and sHLA-G quantitation in serum samples. Results The presence of SV40 antibodies was observed in 6 % of patients affected by MS (N = 4/63), 10 % of OIND (N = 8/77) and 15 % of NIND (N = 9/59), which is suggestive of a lower prevalence in respect to HS (22 %, N = 18/83). MS patients are characterized by higher sHLA-G serum levels (13.9 ± 0.9 ng/ml; mean ± St. Error) in comparison with OIND (6.7 ± 0.8 ng/ml), NIND (2.9 ± 0.4 ng/ml) and HS (2.6 ± 0.7 ng/ml) subjects. Interestingly, we observed an inverse correlation between SV40 antibody prevalence and sHLA-G serum levels in MS patients. Conclusion The data obtained showed a low prevalence of SV40 antibodies in MS patients. These results seems to be due to a generalized status of inability to counteract SV40 infection via antibody production. In particular, we hypothesize that SV40 immune-inhibitory direct effect and the presence of high levels of the immune-inhibitory HLA-G molecules could co-operate in impairing B lymphocyte activation towards SV40 specific peptides.

Published
2016

7. Quality indicators in acute stroke care: a prospective observational survey in 13 Italian regions

Author

Uncini, A, Matera, A, Consoli, D, Romagna, E, Ferro, S, Pallazzoni, P, Nonino, F, Sacquegna, T, Franceschini, M, Guidetti, D, Marcello, N, Liberati, A, Cavina, A, Bellan, M, Facchini, R, Baldissera, S, Grandi, F, Toni, D, Vigna, S, Moisello, A, Ratto, S, Gandolfo, C, Agostoni, E, Dell'Oca, M, Atzeni, L, Deales, A, Papa, R, Provinciali, L, Silvestrini, M, Orlando, A, Cerrato, P, Bramanti, P, Sessa, E, Fierro, I, Bianciardi, L, Inzitari, D, Di, A, Lamassa, M, Nencini, P, Centorrino, S, Accetta, G, Terni, G, Biggeri, A, Zampolini, M, Ricci, S, Agnelli, G, Milia, P, D'Aosta, V, Gaillard, P, Bottacchi, E, Corso, G., DE LUCA, ANDREA, FERRARESE, CARLO, Uncini, A, Matera, A, Consoli, D, Romagna, E, Ferro, S, Pallazzoni, P, Nonino, F, Sacquegna, T, Franceschini, M, Guidetti, D, Marcello, N, Liberati, A, Cavina, A, Bellan, M, Facchini, R, Baldissera, S, Grandi, F, DE LUCA, A, Toni, D, Vigna, S, Moisello, A, Ratto, S, Gandolfo, C, Ferrarese, C, Agostoni, E, Dell'Oca, M, Atzeni, L, Deales, A, Papa, R, Provinciali, L, Silvestrini, M, Orlando, A, Cerrato, P, Bramanti, P, Sessa, E, Fierro, I, Bianciardi, L, Inzitari, D, Di, A, Lamassa, M, Nencini, P, Centorrino, S, Accetta, G, Terni, G, Biggeri, A, Zampolini, M, Ricci, S, Agnelli, G, Milia, P, D'Aosta, V, Gaillard, P, Bottacchi, E, and Corso, G

Subjects
Male, Aging, Multivariate statistics, Multivariate analysis, Quality indicator, Stroke facilities, Quality indicators, Theoretical, Models, 80 and over, Medicine, Acute stroke, Prospective Studies, Prospective cohort study, Multivariate Analysi, Stroke, media_common, Aged, 80 and over, Prospective study, Adult, Aged, Female, Hospitals, Humans, Italy, Middle Aged, Models, Theoretical, Multivariate Analysis, Practice Guidelines as Topic, Standard of Care, Quality Indicators, Health Care, Geriatrics and Gerontology, Medicine (all), Human, medicine.medical_specialty, media_common.quotation_subject, Stroke facilitie, Hospital, Quality monitoring, Quality (business), business.industry, medicine.disease, Health Care, Prospective Studie, Physical therapy, Observational study, business
Abstract

Background and aims: Quality monitoring has great relevance in stroke care. The Project "How to guarantee adherence to effective interventions in stroke care" aimed to estimate adherence to acute-phase guidelines in stroke care in Italy. Methods: A prospective observational study was performed in 27 hospitals of 13 Italian Regions. Adherence to 15 process indicators was evaluated, comparing also stroke units (SU) with conventional wards. An overall score of care, defined as the sum of achieved indicators, was calculated. A multilevel hierarchical model described performance at patient, hospital and regional level. Results: Overall, 484 consecutive stroke patients (mean age, 73.4 years; 52.7% males) were included. Total score ranged from 2 to 15 (mean 8.5 ± 2.4). SU patients were more often evaluated with the National Institutes of Health Stroke Scale (NIHSS) within 24 h, had more frequently an assessment of pre- and post-stroke disability, and a CT scan the same or the day after admission. Regional-hospital- and patient-level variability explained, respectively, 25, 34, and 41% of total score variance. In multivariate models, patients >80 years vs. younger showed a change in total score of -0.45 (95% CI -0.79 to -0.12), and those with NIHSS ≥14 vs. ≤5 of -0.92 (95% CI -1.53 to -0.30). A negative change means a worse adjusted average adherence to process indicators. SU admission increased total score of 1.55 (95% CI 0.52-2.58). Conclusions: Our data confirm the need of quality monitoring in stroke care. Although SU patients showed a better adherence to quality indicators, overall compliance was unsatisfactory. © Springer International Publishing 2013.

Published
2013

8. Expression of 19 microRNAs in glioblastoma and comparison with other brain neoplasia of grades I-III

Author

Visani, M, de Biase, D, Marucci, G, Cerasoli, S, Nigrisoli, E, Bacchi Reggiani ML, Albani, F, Baruzzi, A, Pession, A, Calbucci, F, D'Alessandro, R, Michelucci, R, Brandes, A, Eusebi, V, Ceruti, S, Fainardi, E, Tamarozzi, R, Emiliani, E, Cavallo, M, Franceschi, E, Tosoni, A, Fiorica, F, Valentini, A, Depenni, R, Mucciarini, C, Crisi, G, Sasso, E, Biasini, C, Cavanna, L, Guidetti, D, Marcello, N, Pisanello, A, Cremonini, Am, Guiducci, G, Agati, R, Ambrosetto, G, Bacci, A, Baldin, E, Baldrati, A, Barbieri, E, Bartolini, S, Bellavista, E, Bisulli, F, Bonora, E, Bunkheila, F, Carelli, V, Crisci, M, Dall'Occa, P, Ferro, S, Franceschi, C, Frezza, G, Grasso, V, Leonardi, M, Morandi, L, Mostacci, B, Palandri, G, Pasini, E, Pastore Trossello, M, Poggi, R, Riguzzi, P, Rinaldi, R, Rizzi, S, Romeo, G, Spagnolli, F, Tinuper, P, Trocino, C, Dall'Agata, M, Frattarelli, M, Gentili, G, Giovannini, A, Iorio, P, Pasquini, U, Galletti, G, Guidi, C, Neri, W, Patuelli, A, Strumia, S, Faedi, M, Casmiro, M, Gamboni, A, Rasi, F, Cruciani, G, Cenni, P, Dazzi, C, Guidi, Ar, Zumaglini, F, Amadori, A, Pasini, G, Pasquinelli, M, Pasquini, E, Polselli, A, Ravasio, A, Viti, B, Sintini, M, Ariatti, A, Bertolini, F, Bigliardi, G, Carpeggiani, P, Cavalleri, F, Meletti, S, Nichelli, P, Pettorelli, E, Pinna, G, Zunarelli, E, Artioli, F, Bernardini, I, Costa, M, Greco, G, Guerzoni, R, Stucchi, C, Iaccarino, C, Ragazzi, M, Rizzi, R, Zuccoli, G, Api, P, Cartei, F, Fallica, E, Granieri, E, Latini, F, Lelli, G, Monetti, C, Saletti, A, Schivalocchi, R, Seraceni, S, Tola, Mr, Urbini, B, Giorgi, C, Montanari, E, Cerasti, D, Crafa, P, Dascola, I, Florindo, I, Giombelli, E, Mazza, S, Ramponi, V, Servadei, F, Silini, Em, Torelli, P, Immovilli, P, Morelli, N, Vanzo, C, Nobile, C, Michela Visani, Dario de Biase, Gianluca Marucci, Serenella Cerasoli, Evandro Nigrisoli, Maria Letizia Bacchi Reggiani, Fiorenzo Albani, Agostino Baruzzi, Annalisa Pession, the PERNO study group [, Elena Bonora, and ]

Subjects
Adult, Male, Cancer Research, Low-grade brain tumor, Brain neoplasia, Glioblastoma, Low-grade brain tumors, MicroRNA, Real-time PCR, Aged, Brain Neoplasms, Female, Gene Expression Profiling, Humans, MicroRNAs, Middle Aged, Neoplasm Grading, RNA, Neoplasm, Gene Expression Regulation, Neoplastic, Genetics, Molecular Medicine, Biology, Bioinformatics, medicine.disease_cause, NO, Brain Neoplasm, Genetic, microRNA, medicine, Locked nucleic acid, MicroRNA, Glioblastoma, Brain neoplasia, Low-grade brain tumors, Real-time PCR, Cancer, General Medicine, medicine.disease, Molecular medicine, Fold change, Gene expression profiling, Real-time polymerase chain reaction, Oncology, Cancer research, Carcinogenesis, Corrigendum, Human
Abstract

Several biomarkers have been proposed as useful parameters to better specify the prognosis or to delineate new target therapy strategies for glioblastoma patients. MicroRNAs could represent putative target molecules, considering their role in tumorigenesis, cancer progression and their specific tissue expression. Although several studies have tried to identify microRNA signature for glioblastoma, a microRNA profile is still far from being well-defined. In this work the expression of 19 microRNAs (miR-7, miR-9, miR-9∗, miR-10a, miR-10b, miR-17, miR-20a, miR-21, miR-26a, miR-27a, miR-31, miR-34a, miR-101, miR-137, miR-182, miR-221, miR-222, miR-330, miR-519d) was evaluated in sixty formalin-fixed and paraffin-embedded glioblastoma samples using a locked nucleic acid real-time PCR. Moreover, a comparison of miRNA expressions was performed between primary brain neoplasias of different grades (grades IV-I). The analysis of 14 validated miRNA expression in the 60 glioblastomas, using three different non-neoplastic references as controls, revealed a putative miRNA signature: mir-10b and miR-21 were up-regulated, while miR-7, miR-31, miR-101, miR-137, miR-222 and miR-330 were down-regulated in glioblastomas. Comparing miRNA expression between glioblastoma group and gliomas of grades I-III, 3 miRNAs (miR-10b, mir-34a and miR-101) showed different regulation statuses between high-grade and low-grade tumors. miR-10b was up-regulated in high grade and significantly down-regulated in low-grade gliomas, suggesting that could be a candidate for a GBM target therapy. This study provides further data for the identification of a miRNA profile for glioblastoma and suggests that different-grade neoplasia could be characterized by different expression of specific miRNAs.

Published
2014

9. Definition of miRNAs Expression Profile in Glioblastoma Samples: The Relevance of Non-Neoplastic Brain Reference

Author

Visani, Michela, De Biase, Dario, Marucci, Gianluca, Taccioli, Cristian, Baruzzi, Agostino, Pession, Annalisa, Baruzzi, A., Albani, F., Calbucci, F., D'alessandro, R., Michelucci, R., Brandes, A., Eusebieusebi, V., Ceruti, S., Fainardi, E., Tamarozzi, R., Emiliani, E., Cavallo, M., Franceschi, E., Tosoni, A., Fiorica, F., Valentini, A., Depenni, R., Mucciarini, C., Crisi, G., Sasso, E., Biasini, C., Cavanna, L., Guidetti, D., Marcello, N., Pisanello, A., Cremonini, A. M., Guiducci, G., De Pasqua, S., Testoni, S., Agati, R., Ambrosetto, G., Bacci, A., Baldin, E., Baldrati, A., Barbieri, E., Bartolini, S., Bellavista, E., Bisulli, F., Bonora, E., Bunkheila, F., Carelli, V., Crisci, M., Dall'occa, P., Ferro, S., Franceschi, C., Frezza, G., Grasso, V., Leonardi, M., Mostacci, B., Palandri, G., Pasini, E., Pastore Trossello, M., Poggi, R., Riguzzi, P., Rinaldi, R., Rizzi, S., Romeo, G., Spagnolli, F., Tinuper, P., Trocino, C., Cerasoli, S., Dall'agata, M., Faedi, M., Frattarelli, M., Gentili, G., Giovannini, A., Iorio, P., Pasquini, U., Galletti, G., Guidi, C., Neri, W., Patuelli, A., Strumia, S., Casmiro, M., Gamboni, A., Rasi, F., Cruciani, G., Cenni, P., Dazzi, C., Guidi, A. R., Zumaglini, F., Amadori, A., Pasini, G., Pasquinelli, M., Pasquini, E., Polselli, A., Ravasio, A., Viti, B., Sintini, M., Ariatti, A., Bertolini, F., Bigliardi, G., Carpeggiani, P., Cavalleri, F., Meletti, S., Nichelli, P., Pettorelli, E., Pinna, G., Zunarelli, E., Artioli, F., Bernardini, I., Costa, M., Greco, G., Guerzoni, R., Stucchi, C., Iaccarino, C., Ragazzi, M., Rizzi, R., Zuccoli, G., Api, P., Cartei, F., Fallica, E., Granieri, E., Latini, F., Lelli, G., Monetti, C., Saletti, A., Schivalocchi, R., Seraceni, S., Tola, M. R., Urbini, B., Giorgi, C., Montanari, E., Cerasti, D., Crafa, P., Dascola, I., Florindo, I., Giombelli, E., Mazza, S., Ramponi, V., Servadei, F., Silini, E. M., Torelli, P., Immovilli, P., Morelli, N., Vanzo, C., Nobile, C., M. Visani, D. de Biase, G. Marucci, C. Taccioli, A. Baruzzi, A. Pession, Perno Study Group, F. Albani, V. Eusebi, F. Bisulli, V. Carelli, M. Leonardi, B. Mostacci, P. Tinuper, the PERNO Study group [, E. Bonora, and ]

Subjects
Male, Genetics and Molecular Biology (all), Adult, Aged, Brain, Female, Gene Expression Profiling, Gene Expression Regulation, Neoplastic, Glioblastoma, Humans, MicroRNAs, Middle Aged, Real-Time Polymerase Chain Reaction, Reference Values, Statistics, Nonparametric, Biochemistry, Genetics and Molecular Biology (all), Agricultural and Biological Sciences (all), Gene Expression, Bioinformatics, Biochemistry, Surgical oncology, Nucleic Acids, metabolism, Female, Gene Expression Profiling, Molecular Cell Biology, Basic Cancer Research, Gene expression, normal adjacent the tumor, Neurological Tumors, methods, Gene Expression Regulation, brain tumors, glioblastoma, miRNAs, Multidisciplinary, Cancer Risk Factors, Medicine (all), Statistics, non-neoplastic brain, Real-time polymerase chain reaction, Oncology, miRNAs, Medicine, DNA microarray, brain RNA commercial reference, Research Article, Adult, Aged, Brain, Neoplastic, genetics/physiology, Glioblastoma, metabolism, Humans, Male, MicroRNAs, metabolism, Middle Aged, Real-Time Polymerase Chain Reaction, Reference Values, Statistics, Nonparametric, Science, Brain tumor, Biology, NO, Molecular Genetics, epileptic tissue, Text mining, microRNA, medicine, miRNA, business.industry, Computational Biology, Cancers and Neoplasms, medicine.disease, Gene expression profiling, Gene Expression Regulation, Cancer research, RNA, brain tumors, metabolism, Middle Aged, Real-Time Polymerase Chain Reaction, Reference Values, Statistic, business, metabolism, Humans, Male, MicroRNA, Glioblastoma Multiforme
Abstract

Glioblastoma is the most aggressive brain tumor that may occur in adults. Regardless of the huge improvements in surgery and molecular therapy, the outcome of neoplasia remains poor. MicroRNAs are small molecules involved in several cellular processes, and their expression is altered in the vast majority of tumors. Several studies reported the expression of different miRNAs in glioblastoma, but one of the most critical point in understanding glioblastoma miRNAs profile is the comparison of these studies. In this paper, we focused our attention on the non-neoplastic references used for determining miRNAs expression. The aim of this study was to investigate if using three different non-neoplastic brain references (normal adjacent the tumor, commercial total RNA, and epileptic specimens) could provide discrepant results. The analysis of 19 miRNAs was performed using Real-Time PCR, starting from the set of samples described above and the expression values compared. Moreover, the three different normal RNAs were used to determine the miRNAs profile in 30 glioblastomas. The data showed that different non-neoplastic controls could lead to different results and emphasize the importance of comparing miRNAs profiles obtained using the same experimental condition.

Published
2013

10. Rationale and design of a randomized, double-blind, parallel-group study of terutroban 30 mg/day versus aspirin 100 mg/day in stroke patients: the prevention of cerebrovascular and cardiovascular events of ischemic origin with terutroban in patients with a history of ischemic stroke or transient ischemic attack (PERFORM) study

Author

Bousser, M, Amarenco, P, Chamorro, A, Fisher, M, Ford, I, Fox, K, Hennerici, M, Mattle, H, Rothwell, P, Julian, D, Fieschi, G, Fieschi, C, Boysen, G, Pocock, S, Conard, J, Orgogozo, J, Inzitari, D, Erkinjuntti, T, Pasquier, F, O'Brien, J, Mas, J, Gueret, P, Lenzi, G, Leys, D, Lopez Sendon, J, Norrving, B, Ferro, J, Thygesen, K, Cowpply, B, P, Ameriso, S, Donnan, D, Lang, W, Thijs, V, Fernandes, J, Stamenova, P, Teal, P, Lavados, P, Lu, C, Poljakovic, Z, Kalita, Z, Kaste, M, Moulin, T, Vemmos, K, Diener, H, Wong, L, Nagy, Z, Chopra, J, Mccormack, P, Gensini, G, Budrys, V, Droste, D, Tan, K, Benomar, A, Cantu Brito, C, Barber, A, Koudstaal, P, Thomassen, L, Czlonkowska, A, Cunha, L, Bajenaru, O, Yakhno, N, Chen, C, Lisy, L, Zvan, B, Bryer, A, Kim, J, Vivancos, J, Wahlgren, N, Liu, S, Poungvarin, N, Hentati, F, Bahar, S, Mischenko, T, Lees, K, Abdel Masih, M, Barboza, A, Cirio, J, Crespo, E, Escaray, G, Esnaola, M, Rojas Estol, C, Ferrari, J, Fraiman, H, Garrote, M, Gatto, E, Giannaula, R, Gori, H, Herrera, G, Ioli, P, Losano, J, Povedano Reich, E, Rey, R, Rotta Escalante, R, Saredo, G, Zurru, M, Anderson, C, Bladin, C, Crimmins, D, Davis, S, Donnan, G, Dunbabin, D, Frayne, J, Gates, P, Hankey, G, Helme, R, Herkes, G, Karrasch, J, Kimber, T, Jannes, J, Landau, P, Levi, C, Lueck, C, Markus, R, Phan, T, Schwartz, R, Schultz, D, Blacker, D, Read, S, Williams, M, Aichner, F, Auff, E, Bancher, C, Binder, H, Brainin, M, Brucke, T, Eggers, C, Fertl, E, Ladurner, G, Lalouschek, W, Mamoli, B, Mitrovic, N, Noisternig, G, Schmidt, R, Vosko, M, Willeit, J, Zaruba, E, Boon, P, Bourgeois, P, Caekebeke, J, Cals, N, Cras, P, Desfontaines, P, De Deyn, P, Dieudonne, L, De Klippel, N, Laloux, P, Maertens de Noordhout, A, Merlevede, K, Michotte, A, Pandolfo, M, Peeters, A, Peeters, D, Tack, P, Van Buggenhout, E, Van Landegem, W, Vanhooren, G, Vermylen, P, Annes, M, Brondani, R, De Carvalho, J, Cendes, F, Fabio, S, Ferraz, A, De Freitas, G, Gagliardi, R, Gomes Neto, A, Haussen, S, Kowacs, P, Martins, S, Minelli, C, Moro, C, Noujaim, J, Rocha, M, Da Silva, M, Silveira, J, Yamamoto, F, Zetola, V, Baldaranov, D, Deleva, N, Haralanov, L, Milanov, I, Mintchev, D, Petrova, N, Shotekov, P, Stamenov, B, Zahariev, Z, Arts, R, Bayer, N, Beaudry, M, Berger, L, Bozek, C, Collier, T, Cote, R, Desai, H, Durocher, A, Hachinski, V, Hill, M, Hoppe, B, Howse, D, Mackey, A, Maharaj, M, Minuk, J, Moddel, G, Novak, D, Penn, A, Rabinovitch, H, Selchen, D, Shuaib, A, Silva, J, Silver, F, Spence, D, Stotts, G, Tamayo, A, Teitelbaum, J, Veloso, F, Voll, C, Winder, T, Barrientos Uribe, N, Galdames Poblete, D, Garcia Figueroa, P, Gasic Yaconi, K, Jaramillo Munoz, A, Lavados Germain, P, Lavados Montes, M, Nancupil Bello, C, Prina Pacheco, L, Vargas Canas, A, Venegas, F, Chen, P, H, Cheng, Y, Cui, L, Di, Q, Dong, Q, Fan, D, Feng, H, Huang, Y, Li, J, Li, W, Li, Z, Lin, H, Liu, M, Miao, L, Ren, H, Wang, Y, Wu, J, Zhang, W, Zhao, G, Zhao, H, Zhou, H, Antoncic, I, Demarin, V, Lusic, I, Pavlicek, I, Soldo Butkovic, S, Bar, M, Bauer, J, Kalina, M, Kanovsky, P, Jura, R, Neumann, J, Rektor, I, Skoda, O, Vaclavik, D, Eerola, A, Hillbom, M, Kinnunen, E, Koivisto, K, Numminen, H, Rissanen, A, Roine, R, Sivenius, J, Alamowitch, S, Autret, A, Avendano, S, Bataillard, M, Berthier, E, Besson, G, Bille Turc, F, Boulliat, J, Boulesteix, J, Brosset, C, Cesaro, P, Albucher, J, Clavelou, P, Colamarino, R, Crassard, I, de Broucker, T, de Bray, J, Desbordes, P, Diot, E, Ducrocq, X, Ellie, E, Faucheux, J, Giroud, M, Godefroy, O, Guillon, B, Huttin, H, Just, A, Lamy, C, Lejeune, P, Lucas, C, Macian Montoro, F, Mackowiak, A, Maillet Vioud, M, Pico, F, Milandre, L, Milhaud, D, Malbec, M, Neau, J, Pinel, J, Robin, C, Rodier, G, Rosolacci, T, Rouanet, F, Rouhart, F, Sablot, D, Servan, J, Smadja, D, Trouillas, P, Valance, J, Viader, F, Viallet, F, Wolff, V, Zagnoli, F, Zuber, M, Angerer, M, Becker, U, Berlit, P, Berrouschot, J, Biniek, R, Bitsch, A, Brodhun, R, Dichgans, M, Druschky, K, Dux, R, Faiss, J, Ferbert, A, Gahn, G, Grotemeyer, K, Goertler, M, Grau, A, Griewing, B, Grond, M, Haan, J, Haberl, R, Hamann, G, Hamer, H, Harms, L, Heide, W, Henningsen, H, Hetzel, A, Hoffmann, F, Huber, R, Isenmann, S, Jander, S, Joerg, J, Kaps, M, Kastrup, A, Kessler, C, Koehler, W, Koelmel, H, Lichy, C, Luckner, K, Malessa, R, Mallmann, A, Meyding Lamade, U, Molitor, H, Mueller Jensen, A, Muellges, W, Noth, J, Nueckel, M, Ochs, G, Poppert, H, Roether, J, Rosenkranz, M, Sander, D, Schaebitz, W, Schlachetzki, F, Schlegel, U, Schmid, E, Schneider, D, Schwarz, M, Seidel, G, Sieble, M, Sliwka, U, Stingele, R, Stoegbauer, F, Szabo, K, Topper, R, Treib, J, Weissenborn, K, Widder, B, Witte, O, Karageorgiou, K, Mitsikostas, D, Papadimitriou, A, Papathanasopoulos, P, Chan, H, Ng, P, Tsoi, T, Bartos, L, Csanyi, A, Csiba, L, Csornai, M, Dioszeghy, P, Fazekas, A, Harcos, P, Horvath, S, Kaposzta, Z, Kerenyi, L, Kincses, J, Koves, A, Nikl, J, Panczel, G, Pongracz, E, Sebestyen, K, Semjen, J, Szabo, M, Szegedi, N, Valikovics, A, Varszegi, R, Vecsei, L, Borah, N, Ichaporia, N, Kaul, S, Meenakshi Sundaram, S, Mehndiratta, M, Misra, U, Murthy, J, Nayak, D, Poncha, F, Shah, A, Singh, G, Srinivasa, R, Venkateswarlu, K, Wadia, R, Collins, R, Harbison, J, Hickey, P, Kelly, P, Murphy, S, Adami, A, Agnelli, G, Agostoni, E, Anzola, G, Arnaboldi, M, Bassi, P, Billo, G, Bottacchi, E, Bovi, P, Cappa, S, Cappelletti, C, Carolei, A, Cavallini, A, Chiodo Grandi, F, Comi, G, Consoli, D, Corsi, F, Costanzo, E, De Falco, F, Devetag, F, Di Lazzaro, V, Di Piero, V, Diomedi, M, Fattorello Salimbeni, C, Federico, F, Feleppa, M, Ferrarese, C, Gandolfo, C, Giaccaglini, E, Giaquinto, S, Giobbe, D, Giometto, B, Greco, G, Guidetti, D, Guidotti, M, Iudice, A, Lembo, G, Marengo, C, Marini, P, Melis, M, Micieli, G, Musolino, R, Mutani, R, Neri, G, Parati, E, Pastore, L, Porazzi, D, Prati, P, Procaccianti, G, Rasura, M, Rossini, P, Santilli, I, Semplicini, A, Silvestrini, M, Tanganelli, P, Tedeschi, G, Tezzon, F, Tola, M, Villani, A, Zanferrari, C, Zarcone, D, Bickuviene, I, Gumbrevicius, G, Obelieniene, D, Skaringa, A, Virketiene, I, Tharakan, J, Aleman Pedroza, J, Escamilla Garza, J, Fernandez Vera, J, Leal Cantu, R, Leon Flores, L, Lopez Ruiz, M, Reyes Gutierrez, G, Reyes Morales, S, Rivera Castano, L, Rodrigues Leyva, I, Ruiz Sandoval, J, Vega Boada, F, Belahsen, F, Kissani, N, Mosseddaq, R, Slassi, I, Yahyaoui, M, Boiten, J, Bornebroek, M, De Kort, P, De Leeuw, H, Donders, R, Franke, C, Hertzberger, L, Jansen, B, Kappelle, L, Keizer, K, Kuster, J, Limburg, M, Mulleners, W, Pop, P, Van Den Berg, J, Van Gemert, H, Verbiest, H, Weinstein, H, Clark, M, Fink, J, Gommans, J, Jayathissa, S, Kilfoyle, D, Kumar, A, Hurtig, U, Indredavik, B, Kloster, R, Salvesen, R, Drozdowski, W, Fryze, W, Klimek, A, Kochanowski, J, Kozubski, W, Ksiazkiewicz, B, Kwiecinski, H, Kuczynska Zardzewialy, A, Motta, E, Nowacki, P, Nyka, W, Opala, G, Pierzchala, K, Pniewski, J, Podemski, R, Selmaj, K, Stelmasiak, Z, Stepien, A, Strzelecka Gorzynska, M, Szczudlik, A, Wajgt, A, Wiszniewska, M, Wlodek, A, Canhao, P, Correia, C, Grilo Goncalves, J, Machado Candido, J, Salgado, A, Bulboaca, A, Campeanu, A, Lazar, T, Marginean, I, Minea, D, Pascu, I, Pereanu, M, Perju Dumbrava, L, Popescu, C, Simu, M, Stefanache, F, Toldisan, I, Tuta, S, Zaharia, C, Alifirova, V, Arkhipov, S, Balunov, O, Balyazin, V, Belkin, A, Belova, A, Boiko, A, Bogdanov, E, Butko, D, Chukhlovina, M, Doronin, B, Ermilova, E, Evzelman, M, Fedin, A, Fedorova, N, Golikov, K, Golovkin, V, Gusev, E, Gustov, A, Jakupov, E, Kamchatnov, P, Khabirov, F, Kirienko, A, Klimov, I, Klocheva, E, Kotov, S, Kuznetsov, A, Laskov, V, Levin, Y, Mashkova, N, Nazarov, A, Novikova, L, Odinak, M, Parfenov, V, Pilipenko, P, Pokrovsky, A, Poverennova, I, Rodoman, G, Roshkovskaya, L, Shirokov, E, Shmyriov, V, Sholomov, I, Skoromets, A, Skvortsova, V, Spirin, N, Stakhovskaya, L, Sharov, M, Sherman, M, Shutov, A, Strachunskaya, E, Stulin, I, Suslina, Z, Volosevitch, A, Vorobiev, P, Vorobyeva, O, Voronkova, L, Voskresenskaya, O, Zhuliov, N, Chan, B, Chang, H, Ramani, N, Brozman, M, Dvorak, M, Dzugan, J, Garay, R, Gdovinova, Z, Gurcik, L, Krastev, G, Kukumberg, P, Kurca, E, Meluch, S, Nyeky, M, Turcani, P, Vyletelka, J, Klanjscek, G, Zujovic, E, Zupan, M, Bester, F, Carr, J, Coetzee, C, Frost, A, Gardiner, J, Giampaolo, D, Kesler, S, Lurie, D, Retief, C, Roos, J, Bae, H, Cha, J, Cho, K, Heo, J, Kim, E, Lee, B, Lee, K, Lee, J, Rha, J, Yoon, B, Alvarez Sabin, J, Arboix Damunt, A, De Arce Borda, A, Asensi Alvarez JM, Bermejo Pareja, F, Botia Paniagua, E, Casado, I, Naranjo, I, Castillo Sanchez, J, Chamorro Sanchez, A, Davalos Errando, A, Diaz Marin, C, Diez Tejedor, E, Egido Herrero JA, Fernandez Bolanos, R, Fernandez Fernandez, O, Figuerola Roig, A, Geffner Sclarsky, D, Gil Nunez, A, Gomez Sanchez JC, Gomez Escalonilla Escobar CI, Gonzalez Masegosa, A, Gonzalez Menacho, J, Gracia Fleta, F, Izquierdo Ayuso, G, Jimenez Hernandez, D, Jimenez Martinez, C, Lago Martin, A, Lainez Andres JM, Larracoechea Jausoro, J, Lopez Fernandez JC, Maestre Moreno, J, Marti Vilalta JL, Martin Gonzalez, R, Masjuan Vallejo, J, Medina Rodriguez, A, Molto Jorda JM, Moreno Carre tero MJ, Moris de le Tassa, G, Morlan Gracia, L, Mostacero Miguez, E, Osuna Pulido, T, Pareja Martinez, A, Pinedo Brochado, A, Pons Amate JM, Rodriguez Alvarez JR, Roquer Gonzalez, J, Sanahuja Montesinos, J, Sanchez Sanchez MC, Segura Martin, T, Serena Leal, J, Tejada Garcia, J, Trejo Gabriel JM, Vivancos Mora, J, Andersson, B, Bysell, S, Cederin, B, Laska, A, Lindgren, A, Petersson, T, Wallen, T, Baumgartner, R, Beer, H, Hirt, L, Hungerbuehler, H, Lyrer, P, Michel, P, Mueller, F, Tettenborn, B, Chang, K, Jeng, J, Lien, L, Lin, R, Liu, C, Po, H, Wu, S, Chankrachang, S, Laptikultham, S, Nidhinandana, S, Pongpakdee, S, Benammou, S, Frih Ayed, M, Gouider, R, Mhiri, C, M'Rabet, A, Mrissa, R, Balkan, S, Can, U, Dalkara, T, Kirbas, D, Kumral, E, Ozdemir, G, Ozeren, A, Ozmenoglu, M, Ozturk, S, Lebedynets, V, Maly, V, Moskovko, S, Orzheshkovskyy, V, Smolanka, V, Yavors'Ka, V, Zozulya, I, Bamford, J, Barber, M, Barer, D, Baron, J, Bath, P, Broughton, D, Brown, M, Chataway, J, Curless, R, Darawil, K, Datta, P, Dennis, M, Durairaj, R, Egbuji, J, Ellis, S, Ford, G, Freeman, A, Fulcher, R, Gray, C, Harrington, F, Hudson, C, Iveson, E, James, M, Jenkinson, D, Kalra, L, Kelly, D, Krishnamoorthy, S, Langhorne, P, Magorrian, M, Macleod, M, Macwalter, R, Markus, H, Muhiddin, K, Muir, K, Murphy, P, Power, M, Price, C, Rashed, K, Robinson, T, Rudd, A, Sanmuganathan, P, Sharma, J, Shaw, L, Shetty, H, Smithard, D, Tyrrell, P, Vahidassr, M, Venables, G, Watt, M, White, R, Bousser, M, Amarenco, P, Chamorro, A, Fisher, M, Ford, I, Fox, K, Hennerici, M, Mattle, H, Rothwell, P, Ferrarese, C, PERFORM study, I, PERFORM STUDY, Investigator, Tedeschi, Gioacchino, Cras, Patrick, De Deyn, Peter Paul, and et al.

Subjects
perform study, Male, Thromboxane, International Cooperation, Receptors, Thromboxane, antiplatelet therapy, terutroban, Cardiovascular Disease, Receptors, 80 and over, Stroke, Aged, 80 and over, Aspirin, Ischemic Attack, Transient, Ischemic Attack, Transient, Double-Blind Method, Endpoint Determination, Dose-Response Relationship, Drug, Humans, Aged, Propionates, Naphthalenes, Treatment Outcome, Platelet Aggregation Inhibitors, Cardiovascular Diseases, Middle Aged, Female, Propionic Acids, Neurology, Terutroban, Anesthesia, tp receptor antagonist, stroke, secondary prevention, aspirin, Cardiology, Platelet aggregation inhibitor, Settore MED/26 - Neurologia, stroke prevention, Drug, Cardiology and Cardiovascular Medicine, medicine.drug, Human, medicine.medical_specialty, Dose-Response Relationship, Internal medicine, medicine, Dementia, In patient, business.industry, Platelet Aggregation Inhibitor, schemic, medicine.disease, DementiaI, transient ischemic attack, Ischemic stroke, Human medicine, Neurology (clinical), business, Propionic Acid, Naphthalene
Abstract

Background: Ischemic stroke is the leading cause of mortality worldwide and a major contributor to neurological disability and dementia. Terutroban is a specific TP receptor antagonist with antithrombotic, antivasoconstrictive, and antiatherosclerotic properties, which may be of interest for the secondary prevention of ischemic stroke. This article describes the rationale and design of the Prevention of cerebrovascular and cardiovascular Events of ischemic origin with teRutroban in patients with a history oF ischemic strOke or tRansient ischeMic Attack (PERFORM) Study, which aims to demonstrate the superiority of the efficacy of terutroban versus aspirin in secondary prevention of cerebrovascular and cardiovascular events. Methods and Results: The PERFORM Study is a multicenter, randomized, double-blind, parallel-group study being carried out in 802 centers in 46 countries. The study population includes patients aged ≥55 years, having suffered an ischemic stroke (≤3 months) or a transient ischemic attack (≤8 days). Participants are randomly allocated to terutroban (30 mg/day) or aspirin (100 mg/day). The primary efficacy endpoint is a composite of ischemic stroke (fatal or nonfatal), myocardial infarction (fatal or nonfatal), or other vascular death (excluding hemorrhagic death of any origin). Safety is being evaluated by assessing hemorrhagic events. Follow-up is expected to last for 2–4 years. Assuming a relative risk reduction of 13%, the expected number of primary events is 2,340. To obtain statistical power of 90%, this requires inclusion of at least 18,000 patients in this event-driven trial. The first patient was randomized in February 2006. Conclusions: The PERFORM Study will explore the benefits and safety of terutroban in secondary cardiovascular prevention after a cerebral ischemic event.

Published
2009

11. Magnetic resonance angiography of coronary arteries: assessment in patients with coronary stenosis and control after stent positioning

Author

De Cobelli F, Guidetti D, Angelo Vanzulli, Mellone R, Chierchia S, Del Maschio A, DE COBELLI, Francesco, Guidetti, D, Vanzulli, A, Mellone, R, Chierchia, S, and DEL MASCHIO, Alessandro

Subjects
Adult, Male, Postoperative Care, Humans, Reproducibility of Results, Coronary Disease, Female, Stents, Middle Aged, Magnetic Resonance Angiography, Aged
Abstract

INTRODUCTION: Cardiovascular disease remains the leading cause of death in the world. Invasive coronary angiography is currently the only clinical method available to visualize the coronary arteries, with up to 20% of the procedures demonstrating no evidence of severe coronary artery stenoses. We investigated the role of two-dimensional (2D) coronary magnetic resonance angiography (MRA) in patients with suspected coronary arteries disease and to check the placement and the patency of previously placed coronary artery stents. MATERIAL AND METHODS: Eleven patients with suspected coronary artery disease who underwent elective cardiac catheterization with coronary angiography were examined with 2D coronary MRA to detect coronary artery stenoses. Other 11 patients with 13 stented coronary arteries (6 RCA, 5 LAD, 2 Lcx) were prospectively examined with MRA one day to 8 months after stent placement. Eighteen amagnetic stents were imaged. Imaging was performed with a 1.5 T MR unit (GE Signa Horizon Echo Speed) with a phased array multicoil. Segmented k-space fast GE sequences were acquired with and without fat suppression at several cardiac cycle phases within a single breath-hold. Correlation with coronary angiography was performed in all patients. RESULTS: Thirteen significant stenoses were found at coronary angiography in 11 coronary arteries. The sensitivity and specificity of MR coronary angiography, as compared with conventional angiography, in correctly identifying the single vessels with > 50% angiographic stenoses were 73% and 94%, respectively. The corresponding positive and negative predictive values and accuracy were 88%; 84% and 86%, respectively. As far as the study of coronary artery stents is concerned, no MR-related adverse events were observed. The stents were visualized as signal loss areas. The length of the signal loss corresponded to the length of the stents in all 18 cases (r = 97). The patent blood flow distal to the stents appeared as a high-signal band distal to the signal void, corresponding to stent patency at coronary angiography. CONCLUSIONS: Although in an early stage of technical development, 2D coronary MRA can depict 73% of hemodynamically severe coronary artery stenoses. Moreover breath-hold coronary cine MRA is a safe technique to visualize coronary artery stents. Stent site and patency can be noninvasively studied with this technique

Published
1998

12. Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke

Author

Hacke, Werner, Kaste, Markku, Bluhmki, Erich, Brozman, Miroslav, Dávalos, Antoni, Guidetti, Donata, Larrue, Vincent, Lees, Kennedy R., Medeghri, Zakaria, Machnig, Thomas, Schneider, Dietmar, Von Kummer, Rüdiger, Wahlgren, Nils, Toni, Danilo, Hacke, W, Dávalos, A, Kaste, M, von Kummer, R, Larrue, V, Toni, D, Wahlgren, N, Lees, Kr, Heiss, Wd, Lesaffre, E, Orgogozo, Jm, Bastianello, S, Wardlaw, Jm, Peyrieux, Jc, Sauce, C, Medeghri, Z, Mazenc, R, Machnig, T, Bluhmki, E, Aichner, F, Alf, C, Baumhackl, U, Brainin, M, Eggers, C, Gruber, F, Ladurner, G, Niederkorn, K, Noistering, G, Willeit, J, Vanhooren, G, Blecic, S, Bruneel, B, Caekebeke, J, Laloux, P, Simons, Pj, Thijs, V, Bar, M, Dvorakova, H, Vaclavik, D, Boysen, G, Andersen, G, Iversen, Hk, Traberg-Kristensen, B, Marttila, R, Sivenius, J, Trouillas, P, Amarenco, P, Bouillat, J, Ducrocq, X, Giroud, M, Jaillard, A, Larrieu, Jm, Leys, D, Magne, C, Mahagne, Mh, Milhaud, D, Sablot, D, Saudeau, D, Busse, O, Berrouschot, J, Faiss, Jh, Glahn, J, Görtler, M, Grau, A, Grond, M, Haberl, R, Hamann, G, Hennerici, M, Koch, H, Krauseneck, P, Marx, J, Meves, S, Meyding-Lamadé, U, Ringleb, P, Schneider, D, Schwarz, A, Sobesky, J, Urban, P, Karageorgiou, K, Komnos, A, Csányi, A, Csiba, L, Valikovics, A, Agnelli, G, Billo, G, Bovi, P, Comi, G, Gigli, G, Guidetti, D, Inzitari, D, Marcello, N, Marini, C, Orlandi, G, Pratesi, M, Rasura, M, Semplicini, A, Serrati, C, Tassinari, T, Brouwers, Pj, Stam, J, Naess, H, Indredavik, B, Kloster, R, Czlonkowska, A, Kuczyńska-Zardzewialy, A, Nyka, W, Opala, G, Romanowicz, S, Cunha, L, Correia, C, Cruz, V, Pinho e Melo, T, Brozman, M, Dvorak, M, Garay, R, Krastev, G, Kurca, E, Alvarez-Sabin, J, Chamorro, A, del Mar Freijo Guerrero, M, Herrero, Ja, Gil-Peralta, A, Leira, R, Martí-Vilalta, Jl, Masjuan Vallejo, J, Millán, M, Molina, C, Mostacero, E, Segura, T, Serena, J, Vivancos Mora, J, Danielsson, E, Cederin, B, Von, Zweigberg, Wahlgren, Ng, Welin, L, Lyrer, P, Bogousslavsky, J, Hungerbühler, Hj, Weder, B, Ford, Ga, Jenkinson, D, Macleod, Mj, Macwalter, Rs, Markus, Hs, Muir, Kw, Sharma, Ak, Walters, Mr, Warburton, Ea, ACS - Amsterdam Cardiovascular Sciences, ANS - Amsterdam Neuroscience, and Neurology

Subjects
Adult, Male, Time Factors, medicine.medical_treatment, Placebo, Drug Administration Schedule, Brain Ischemia, Brain ischemia, Double-Blind Method, Fibrinolytic Agents, Modified Rankin Scale, medicine, Odds Ratio, Desmoteplase, Humans, Infusions, Intravenous, Stroke, Aged, business.industry, Cerebral infarction, Medicine (all), General Medicine, Thrombolysis, Middle Aged, medicine.disease, Logistic Models, Treatment Outcome, Anesthesia, Tissue Plasminogen Activator, Acute Disease, Female, business, Intracranial Hemorrhages, Fibrinolytic agent
Abstract

Background Intravenous thrombolysis with alteplase is the only approved treatment for acute ischemic stroke, but its efficacy and safety when administered more than 3 hours after the onset of symptoms have not been established. We tested the efficacy and safety of alteplase administered between 3 and 4.5 hours after the onset of a stroke. Methods After exclusion of patients with a brain hemorrhage or major infarction, as detected on a computed tomographic scan, we randomly assigned patients with acute ischemic stroke in a 1:1 double-blind fashion to receive treatment with intravenous alteplase (0.9 mg per kilogram of body weight) or placebo. The primary end point was disability at 90 days, dichotomized as a favorable outcome (a score of 0 or 1 on the modified Rankin scale, which has a range of 0 to 6, with 0 indicating no symptoms at all and 6 indicating death) or an unfavorable outcome (a score of 2 to 6 on the modified Rankin scale). The secondary end point was a global outcome analysis of four neurologic and disability scores combined. Safety end points included death, symptomatic intracranial hemorrhage, and other serious adverse events. Results We enrolled a total of 821 patients in the study and randomly assigned 418 to the alteplase group and 403 to the placebo group. The median time for the administration of alteplase was 3 hours 59 minutes. More patients had a favorable outcome with alte plase than with placebo (52.4% vs. 45.2%; odds ratio, 1.34; 95% confidence interval [CI], 1.02 to 1.76; P = 0.04). In the global analysis, the outcome was also improved with alteplase as compared with placebo (odds ratio, 1.28; 95% CI, 1.00 to 1.65; P

Published
2008

13. The Italian multicenter observational study on post-stroke depression (DESTRO)

Author

Paolucci, S. T., Gandolfo, C., Provinciali, L., Torta, R., TOSO AND ON THE BEHALF OF THE DESTRO STUDY GROUP, V., Lagalla, THE DESTRO STUDY GROUP INCLUDES G., Manicone, M. G., Del, M., Gobbo, Paolini, S., Ancona, Bottacchi, E., Corso, G., Aosta, Federico, F., Martino, D, Bari, Salsa, F., Turinese, E., BASSANO DEL GRAPPA VI, Gentile, M., Bogo, S., Belluno, Crisci, M., Sacquegna, T., Bologna, Santamato, V., Pietrarossa, G., Carbonara, Ba, Coppola, G., Toni, V., Trianni, G., Casarano, Le, Pennisi, Giovanni, Bella, Rita, Catania, Ricci, S., Amantini, K., Città, DELLA PIEVE PG, Buzzelli, S., DI FRANCESCO, L., ANGELO PE, CITTÀ S., Antonelli, B, Pelliccia, G., Fermo, Ap, Paolino, E., Iezzi, E., Ferrara, P, Nencini, Sarti, C., Florence, Neri, W., Galletti, G., Forli, Pretta, S., Sette, Genoa, Giaccaglini, E., Sconocchini, C., Iesi, An, Carolei, A., Capannolo, C, Laquila, Musolino, R., Gangemi, S., Vita, G., DI LEO, R., Messina, Comola, M., Mammi, S., Zamperetti, M. A., Defanti, C. A., Milan, DE FALCO, F. A., Santangelo, R., Scarano, V., Naples, M. T, Giordana, Sciolla, R., Orbassano, To, Meneghetti, G., Ottina, M., Padua, Ponari, A., Castiglia, R., Palermo, Mancia, D., Zanferrari, C., Parma, Micieli, G., Zambrelli, E., Pavia, Cardaioli, G., Gallai, V., Perugia, Badino, R., Tassinari, T., PIETRA LIGURE SV, Orlandi, G., Fanucchi, S., Pisa, Ciucci, G., Padoan, G., Ravenna, Gasparini, F., Guidetti, D., Reggio, Emilia, DE ANGELIS, D., Amabile, G. A., Fiermonte, G., Rome, Roberti, C., Foti, A., Roma, Cainelli, L., Chiusole, M., Rovereto, Tn, Pasqualino, S., Intiso, D., GIOVANNI ROTONDO FG, S., Tonizzo, M., Basile, A., VITO AL, S., Tagliamento, Pn, Viviani, P., SANT ARSENIO SA, Stromillo, M. L., Federico, A, Siena, Liboni, W., Pavanelli, E., Bergamasco, B., Cerrato, P., Boghi, A, Cicolin, A., Berra, C., Turin, Zorzon, M., Tommasi, M. A., Chiodo, F., Grandi, Koscica, N., Trieste, Micoli, B., Lorio, R., Venice, Bovi, P., Trabucco, G., Verona, Consoli, D., Galati, F., and Vibo, Valentia

Subjects
Adult, Male, medicine.medical_specialty, Pediatrics, Time Factors, Adolescent, Personality Inventory, Physical examination, Observation, Disability Evaluation, Quality of life, medicine, History of depression, Post-stroke depression, Humans, Psychiatry, Stroke, Depression (differential diagnoses), Aged, Retrospective Studies, Aged, 80 and over, Psychiatric Status Rating Scales, Chi-Square Distribution, medicine.diagnostic_test, Depression, Beck Depression Inventory, Retrospective cohort study, Middle Aged, medicine.disease, Neurology, Italy, Female, Neurology (clinical), Psychology
Abstract

Despite growing information, questions still surround various aspects of post-stroke depression (PSD). The Italian multicenter observational study Destro was designed to help clarify in a large sample the frequency and clinical impact of PSD. A total of 53 centers consecutively admitted 1064 patients with ischemic or hemorrhagic stroke, assessing them periodically in the first 9 months after the event. Patients with depression were followed for two years. Depression was diagnosed on clinical examination, verbal (Beck Depression Inventory) and non-verbal rating systems (Visual Analog Mood Scale), identifying the nosographic condition attributable to the mental state. The patient's clinical history, residual independence, and post-ictus quality of life were also taken into account. PSD was detected in 383 patients (36 %), most of whom had minor depression (80.17 %), with dysthymia, rather than major depression and adaptation disorder. About 80% developed depression within three months of the stroke. Cases with later onset tended to have less severe symptoms. Risk factors were a history of depression, severe disability, previous stroke and female sex, but not the type and site of the vascular lesion. PSD was not correlated with any increase in mortality or cerebrovascular recurrences, but these patients had lower autonomy and quality of life ratings. In conclusion, patients should be close observed in the first few weeks after a stroke in order to check for depression,which is more likely in those with clear risk factors and may spoil their quality of life.

Published
2006

14. Quantification of the risk of post stroke depression : the Italian multicenter observational study DESTRO

Author

Paolucci, S., Gandolfo, C., Provinciali, L., Torta, R., SOMMACAL ON BEHALF OF, S., DESTRO STUDY GROUP AND, Lagalla, V. TOSOPARTICIPANTS IN THE DESTRO STUDY INCLUDE G., M. G, Manicone, DEL GOBBO, M., Paolini, S., Ancona, Bottacchi, E., Corso, G., Aosta, Federico, F., Martino, D., Bari, Salsa, F., Turinese, E, BASSANO DEL GRAPPA VI, Gentile, M., Bogo, S., Belluno, Crisci, M., Sacquegna, T., Bologna, Santamato, V., Pietrarossa, G, Carbonara, Ba, Coppola, G., Toni, V., Trianni, G, Casarano, Le, Pennisi, Giovanni, Bella, Rita, Catania, S, Ricci, Amantini, K., CITTA DELLA PIEVE PG, Buzzelli, S., Di, L., Francesco, ANGELO PE, CITTA S., Antonelli, B., Pelliccia, G., Fermo, Ap, Paolino, E., Iezzi, E., Ferrara, Nencini, P., Sarti, C., Florence, Neri, W., Galletti, G., Forli, Pretta, S., DEL SETTE, M., Genoa, Giaccaglini, E., Sconocchini, C., Iesi, An, Carolei, A., Capannolo, C., Laquila, Musolino, R., Gangemi, S., Vita, G., DI LEO, R., Messina, Comola, M., Mammi, S., Zamperetti, M. A., Defanti, C. A., Grassivaro, N., Rudelli, G., Milan, F. A., De, Falco, Santangelo, R., Scarano, V., Naples, M. T, Giordana, Sciolla, R., Orbassano, To, Meneghetti, G., Ottina, M, Padua, Ponari, A., Castiglia, R., Palermo, Mancia, D., Zanferrari, C, Parma, Micieli, G., Zambrelli, E., Pavia, Cardaioli, G., Gallai, V., Perugia, Badino, R., Tassinari, T., Pietra, Ligure, Orlandi, G., Fanucchi, S., Pisa, Ciucci, G., Padoan, G., Ravenna, Gasparini, F., Guidetti, D., Reggio, Emilia, De, D., Angelis, Amabile, G. A., FIERMONTE ROME, G., Roberti, C., Foti, A, Roma, Cainelli, L., Chiusole, M., Rovereto, Tn, Pasqualino, S, Intiso, D., GIOVANNI ROTONDO FG, S., Tonizzo, M., Basile, A., VITO AL TAGLIAMENTO PN, S., Viviani, P., Santarsenio, Sa, Stromillo, M. L., Federico, A., Siena, W, Liboni, Pavanelli, E., Bergamasco, B., Cerrato, P., Boghi, A., Cicolin, A, Berra, C., Turin, Zorzon, M., Tommasi, M. A., F, Chiodo, Grandi, Koscica, N., Trieste, Micoli, B., Lorio, R., Venice, Bovi, P., Trabucco, G., Verona, Consoli, D., Galati, F., Vibo, Valentia, Bortolon, F., Morra, M., Vicenza, and Crespi, V.

Subjects
Adult, Male, Pediatrics, medicine.medical_specialty, Multivariate analysis, Adolescent, Sex Factors, Risk Factors, mental disorders, medicine, Humans, Disabled Persons, Risk factor, Stroke, Depression (differential diagnoses), Aged, Aged, 80 and over, Psychiatric Status Rating Scales, Depression, business.industry, Beck Depression Inventory, Middle Aged, medicine.disease, Psychiatry and Mental health, Mood, Italy, Relative risk, Physical therapy, Female, Observational study, business, Follow-Up Studies
Abstract

Objective: The Italian multicenter observational study depression in stroke (DESTRO) aimed to identify risk factors for poststroke depression (PSD) and quantify the likelihood of it arising in various categories of patients. Method: Mood evaluation was performed in 1064 consecutive stroke patients by means of Beck Depression Inventory and Visual Analog Mood Scale. Depressive symptoms were classified using the DSM-IV and revised WHO criteria for depression in the course of a neurological disorder. Results: Poststroke depression was seen in 36% of the survivors, with dysthymia by far the predominant form (80.7%). Female sex, disability, previous cerebrovascular or depressive episodes were significantly associated with an increased risk of depression. Combinations of these factors raised the risk of PSD exponentially, from 24.3 to 89.1%. The site of the stroke did not come into the uni- or multivariate analysis. Conclusion.: At admission, it is possible to predict the likelihood of PSD and quantify the relative risk.

Published
2005

15. Left:right side ratio of endometriotic implants in the pelvis

Author

Parazzini, F, Tranquilli, A, Fanizza, G, Stella, M, Traina, V, Fasolino, A, Giuliano, M, Ardovino, I, Struzziero, E, Radici, E, Zanardi, E, Pungetti, D, Falsetti, L, Zanagnolo, V, Mais, V, Paoletti, Am, Ajossa, S, Melis, Gb, Catania, Mignami, G, Garozzo, A, Giuffrida, G, Palumbo, G, Massi, Gb, Pellegrini, S, Semino, A, Venturini, Pl, Crosignani, Pg, Ragni, G, Colombo, P, Gruft, L, Busacca, M, Vignali, M, Garcea, N, La Manna, Ma, Giannini, P, Cesa, F, Romano, Gv, Bergoglio, S, Trossarelli, Gf, Guidetti, D, Massobrio, M, Marsoni, V, Gervasi, Mt, Bracco, Gl, Scarselli, G, Beretta, P, Franchi, M, Balducci, A, Vercellini, P, and Chatenoud, L .

Subjects
Adult, medicine.medical_specialty, Adolescent, Gauche effect, Sterility, Epidemiology, medicine.medical_treatment, Endometriosis, Distribution, Pelvic Pain, Pelvis, Laparotomy, medicine, Confidence Intervals, Humans, Laparoscopy, medicine.diagnostic_test, business.industry, Pelvic pain, Obstetrics and Gynecology, Middle Aged, medicine.disease, Confidence interval, Surgery, Transplantation, Ovarian Cysts, medicine.anatomical_structure, Reproductive Medicine, Female, Distribution, Endometriosis, Epidemiology, Implant, medicine.symptom, business
Abstract

Objective : The frequency of endometriotic lesions in the right and left hemipelvis was analysed in 856 women with endometriosis. Eligible for the study were women with primary or secondary sterility, chronic pelvic pain, fibroids or benign ovarian cysts requiring laparoscopy or laparotomy consecutively observed between May 1991 and July 1992 in 23 obstetric and gynecology departments in Italy. Women with a previous diagnosis of endometriosis were excluded. A total of 3684 women entered the study. Of those, 856 had endometriosis and are considered in the present analysis. Results : Five hundred and ninety four had bilateral lesions (including both ovarian and peritoneal lesions). Of the 262 women with unilateral lesions, 118 (45%, 95% confidence intervals (CI) 38–54) had the lesions in the right side of the pelvis and 144 (55%) in the left one. Conclusions : From an anatomical point of view, these findings support the transplantation therapy in the pathogenesis of endometriosis.

Published
2003

16. Estroprogestin vs. gonadotrophin agonists plus estroprogestin in the treatment of endometriosis-related pelvic pain: a randomized trial. Gruppo Italiano per lo Studio dell'Endometriosi

Author

Parazzini, F, Di Cintio, E, Chatenoud, L, Moroni, S, Ardovino, I, Struzziero, E, Falsetti, L, Bianchi, A, Bracco, G, Pellegrini, A, Bertulessi, C, Romanini, C, Zupi, E, Massobrio, M, Guidetti, D, Troiano, L, Beretta, P, and Franchi, Massimo Piergiuseppe

Subjects
Adult, Triptorelin Pamoate, Estroprogestin vs. gonadotrophin agonists plus estroprogestin in the treatment of endometriosis-related pelvic pain: a randomized trial. Gruppo Italiano per lo Studio dell'Endometriosi, Estradiol, Endometriosis, Pain, Gonadotropin-Releasing Hormone, Luteolytic Agents, Dysmenorrhea, Humans, Female, Progesterone, Follow-Up Studies, Pain Measurement
Abstract

This is a randomized clinical trial comparing estroprogestin (E/P) pill given for 12 months vs. gonadotrophin releasing hormone agonist (GNRHa) given for 4 months followed by E/P pill treatment for 8 months in the relief of endometriosis-related pelvic pain.Eligible for the study were women with laparoscopically confirmed endometriosis and pelvic pain lasting 3-12 months after diagnosis. Eligible women were randomly assigned to treatment with E/P pill (gestroden 0.75 mg and ethynlestradiol 0.03 mg) for 12 months (47 patients) vs. tryptorelin 3.75 mg slow release every 28 days for 4 months followed by E/P pill for 8 months (55 patients).At baseline, dysmenorrhea was reported in 46 women allocated to E/P pill only (97.9%), and in all the 55 women allocated to GNRHa+E/P pill. The corresponding value at the 12 months follow-up visit was 14 subjects (35.9%) and 16 subjects (34.8%). The baseline median values of the multidimensional and analog scale were for dysmenorrhea 4 and 6 in the EP only and 3 and 6 in the GNRHa+E/P group. The corresponding value at the 12 months follow-up visit were 2 and 6 and 0 and 5. Non-menstrual pain was reported, respectively, at baseline and 12 month visit by 46 (97.9%) and 15 (38.5%) subjects in the E/P pill group and 49 (89.1%) and 17 (37.0%) of the GNRHa+E/P pill one. The baseline median values of the multidimensional and analog scale were for non-menstrual pain 3 and 5 in the E/P only and 2 and 6 in the GNRHa+E/P group. The corresponding values at the 12 month follow-up visit were 0 and 4 and 0 and 4. These differences between the two groups were not statistically significant.1 year after randomization, the two treatment schedules show similar relief of pelvic pain in women with endometriosis.

Published
2000

17. A randomized study on eversion versus standard carotid endarterectomy: study design and preliminary results: the Everest Trial

Author

Cao, Piergiorgio, Giordano, G, DE RANGO, Paola, Zannetti, S, Chiesa, R, Coppi, G, Palombo, D, Spartera, C, Stancanelli, V, Vecchiati, E, Caporali, S, Lenti, M, Maghini, M, Nardeli, L, Parente, B, Parlani, Gianbattista, Verzini, Fabio, Celani, Mg, Nora, A, Malferrari, G, Peinetti, F, Cifiello, Bi, Udini, M, D'Allesandro, G, DI GIOVANNI, Maria Vittoria, Castellano, R, Melisanno, G, Magnani, G, Truci, G, Piccinini, E, Santioni, R, Rebucci, Gg, Bafile, G, Gizzi, E, Ventura, M, Varroni, A, Aloisi, P, Tusini, N, Guidetti, D, Moggi, Luigi, Sensi, B, Nenci, Giuseppe Giorgio, Cantisani, T, DEL FAVERO, Albano, Ricci, S, Righetti, E, Setacc, Cao, P, Giordano, G, DE RANGO, P, Zannetti, S, Chiesa, Roberto, Coppi, G, Palombo, D, Spartera, C, Stancanelli, V, and Vecchiati, E.

Subjects
Carotid Artery Diseases, Male, SYMPTOMS, Time Factors, medicine.medical_treatment, Myocardial Infarction, Carotid endarterectomy, law.invention, ARTERY STENOSIS, DUPLEX CRITERIA, MANAGEMENT, STROKE, Randomized controlled trial, law, Recurrence, Odds Ratio, Carotid Stenosis, Intraoperative Complications, Stroke, Endarterectomy, Aged, 80 and over, Endarterectomy, Carotid, Hematoma, Carotid Artery Diseases/treatment, Incidence, Middle Aged, Constriction, Survival Rate, Treatment Outcome, Ischemic Attack, Transient, Research Design, Anesthesia, Female, Cardiology and Cardiovascular Medicine, Adult, medicine.medical_specialty, Carotid Artery Diseases/etiology, Arterial Occlusive Diseases, Arteriovenous Shunt, Surgical, Multicenter trial, medicine, Confidence Intervals, Humans, Survival rate, Cranial Nerve Injuries, Carotid Stenosis/surgery, Aged, Carotid/methods, business.industry, Perioperative, medicine.disease, Surgery, Stenosis, Cerebrovascular Disorders, Follow-Up Studies, business, Neck
Abstract

Purpose: The EVEREST Trial was designed to determine whether the surgical technique influences the durability and complications of carotid endarterectomy (CEA). The current report focuses on the study design and preliminary results. Methods: EVEREST is a randomized multicenter trial. A total of 1353 patients with carotid stenosis requiring surgical treatment were randomly assigned to received standard (n = 675) or eversion (n = 678) CEA. Primary end points included carotid occlusion, major stroke, death, and restenosis rate. Results: The rate of perioperative major stroke and death (1.3 for each study group) and the incidence of early carotid occlusion (0.6% for eversion vs 0.4% for standard) were similar. No significant differences were found between eversion and standard CEA with respect to incidence of perioperative transient ischemic accident, minor stroke, cranial nerve injuries, neck hematoma, myocardial infarction, or surgical defects as detected with intraoperative quality controls. Clamping time was significantly shorter for eversion CEA compared with patch standard procedures (31.7 ± 15.9 vs 34.5 ± 14.4 minutes, p = 0.02). A shunt was inserted in 11% of patients undergoing eversion CEAs and in 16% of patients undergoing standard procedures. Overall 30-day events occurred in 13.3% of the eversion group and in 11.4% of the standard group ( p = 0.3). At a mean follow-up of 14.9 months (range, 1 to 38 months), 16 (2.4%) restenoses occurred in the eversion group and 28 (4.1%) occurred in the standard group (odds ratio, 0.56; 95% confidence interval, 0.3 to 1.1; p = 0.08). Conclusion: The preliminary results of the EVEREST Trial suggest that eversion CEA is a safe and rapid procedure with low major complication rates. No significant differences in restenosis rates were observed between eversion and standard CEA at the available follow-up. Longer-term results are necessary to assess whether the eversion technique influences the durability of CEA. (J Vasc Surg 1998;27:595-605.)

Published
1998

18. Post-stroke rehabilitation in Italy: inconsistencies across regional strategies

Author

Guidetti, D., Spallazzi, M., Marzia Baldereschi, Di Carlo, A., Ferro, S., Rota, E., Morelli, N., Immovilli, P., Toni, D., Polizzi, B. M., and Inzitari, D.

Subjects
Aged, 80 and over, Male, Health Policy, Stroke Rehabilitation, Rehabilitation Centers, Aged, Cross-Sectional Studies, Disabled Persons, Female, Humans, Italy, Retrospective Studies, Stroke, Disability Evaluation, 80 and over
Abstract

Remarkable differences among European countries have been found in stroke rehabilitation models, owing to the fact that stroke rehabilitation services are embedded in health care systems. Comprehensive data on service utilization by stroke survivors in Italy are lacking, but would be instrumental in improving efficiency and effectiveness of post-acute stroke care, and consequently, in containing costs and improving outcomes.The purpose of the present study was to survey the Italian regional legislations in order to examine the provision of rehabilitation services for stroke survivors in Italy.This is a cross-sectional, observational study.Post-stroke intra- and extra-hospital rehabilitation.All decrees and resolutions as to post-acute stroke rehabilitation were collected from each Italian region.All decrees and resolutions were examined by the means of a check list including quantitative and qualitative characteristics, selected in accordance with national official recommendations. Each completed check list was then sent to each regional reference person, who filled in the section on the implementation of the indications and compliance.The study was carried out from November 2009 to September 2010. The documents were collected from 19 out of the 20 Italian regions. The results of the study indicate that there are many, remarkable regional variations in health policies concerning post-stroke care. Instruments for evaluation and criteria for allocating stroke patients to proper rehabilitation setting vary across regions, but data on the potential impact of these variations on clinical outcomes are still lacking.The study highlights the issue that, in Italy, delivery of post-stroke rehabilitation services is not uniform nation-wide and varies substantially across regions. The lack of a comprehensive post-acute stroke strategy is a major obstacle to service availability.The study results advocate the need for a consistent and comprehensive strategic planning of post-stroke rehabilitation in Italy.

19. First evidence of a pathogenic insertion in the NOTCH3 gene causing CADASIL

Author

Donata Guidetti, Francesca Luisa Conforti, Rosalucia Mazzei, Luigi Citrigno, Angela Magariello, Aldo Quattrone, Pier Luigi Lanza, A. L. Gabriele, Maria Muglia, Alessandra Patitucci, Carmine Ungaro, Patrizia Riguzzi, P. Preda, Teresa Sprovieri, Giovanna Cenacchi, Mazzei R., Guidetti D., Ungaro C., Conforti F.L., Muglia M., Cenacchi G., Lanza P.L., Patitucci A., Sprovieri T., Riguzzi P., Magariello A., Gabriele A.L., Citrigno L., Preda P., and Quattrone A.

Subjects
Adult, Pathology, medicine.medical_specialty, Mutation, Missense, CADASIL, Transient ischaemic attacks, Biology, Angiopathy, INDEL Mutation, medicine, Missense mutation, Humans, Vascular dementia, Receptor, Notch3, Receptors, Notch, Vascular disease, Brain, CADASIL Syndrome, medicine.disease, Magnetic Resonance Imaging, Migraine with aura, Temporal Lobe, Frontal Lobe, Pedigree, Psychiatry and Mental health, Phenotype, Surgery, Female, Neurology (clinical), medicine.symptom
Abstract

CADASIL (OMIM 125310) is an increasingly recognised adult-onset autosomal-dominant vascular disease that is characterised by recurrent transient ischaemic attacks and strokes (43% of patients), vascular dementia (6%), migraine with aura (40% of patients) and psychiatric disturbances (9% of patients); epilepsy has been reported in 2–10% of subjects.1 All patients revealed prominent signal abnormalities on brain magnetic resonance imaging (MRI)—leukoencephalopathy on T2- and small subcortical infarcts on T1-weighted images.2 The pathological hallmark of CADASIL is a non-amyloid and non-arteriosclerotic angiopathy, which predominantly affects the small penetrating brain arteries. Vascular lesions are characterised by degeneration and loss of smooth-muscle cells and by the presence of granular osmiophilic material (GOM) accumulating within the smooth-muscle-cell basement membrane and the surrounding extracellular matrix. Examination of several peripheral organs revealed vessel changes, including the presence of GOM deposits, providing evidence that CADASIL is a systemic arteriopathy.3 It has been reported that CADASIL is caused by single missense mutations, small in-frame deletions or splice-site mutations in the NOTCH3 gene encoding a transmembrane receptor (http://www.hgmd.cf.ac.uk/ac/gene.php?gene = NOTCH3). Almost all previously reported mutations resulted in an odd number of cysteine residues within one of the 34 epidermal growth factor (EGF)-like repeats in the …

Published
2008

20. Transcatheter patent foramen ovale closure mitigates aura migraine headaches abolishing spontaneous right-to-left shunting

Author

Daniela Prandstraller, D. Guidetti, Roberto Formigari, Alessandro Giardini, Oscar Gaddi, Gualtiero Palareti, Fernando M. Picchio, Marco Bonvicini, Andrea Donti, Luisa Salomone, Giardini A, Donti A, Formigari R, Salomone L, Prandstraller D, Bonvicini M, Palareti G, Guidetti D, Gaddi O, and Picchio FM

Subjects
Male, Adult, medicine.medical_specialty, Cardiac Catheterization, Heart Catheterization, Aura, medicine.medical_treatment, Migraine Disorders, Heart Septal Defects, Atrial, Coronary Circulation, Medicine, Humans, Thrombophilia, migraine, Cardiac catheterization, Retrospective Studies, Heart septal defect, business.industry, Retrospective cohort study, Prostheses and Implants, Middle Aged, medicine.disease, Transcranial Doppler, Surgery, Migraine, Patent foramen ovale, Female, Heart Septal Defect, Headaches, medicine.symptom, Cardiology and Cardiovascular Medicine, business
Abstract

Background: Patent foramen ovale (PFO) has been implicated in the etiology of migraine headache with aura (MHA), but the mechanisms that link right-to-left (R-to-L) shunt to MHA are unclear, and the reports on the efficacy of transcatheter PFO closure on MHA prevention are scarce. Methods: We reviewed the clinical records of 131 consecutive patients who underwent successful transcatheter PFO closure at our institution at a mean age of 45 ± 13 years because of cryptogenic stroke. Of the 131 patients, 35 (27%) had a diagnosis of MHA made by the primary care physician or the referring neurologist. Migraine headache with aura incidence and severity were assessed by using Migraine Disability Assessment (MIDAS) questionnaire. Presence and magnitude of R-to-L shunt were assessed in all patients by means of transesophageal echocardiography and also by means of transcranial Doppler (TCD) in the last 50 patients (38%). Results: Patients with MHA had a higher prevalence of thrombophilia (P = .007), a more complex atrial septal anatomy (P = .001), and they also had higher prevalence of spontaneous R-to-L shunt and of spontaneous large shunt, both at transesophageal echocardiography (P = .015, and .028, respectively) and at TCD (P = .036, and .038, respectively). After the procedure, 32 (91%) of 35 patients had either complete resolution or significant improvement in their MHA. At a mean follow-up of 1.7 ± 1.3 years, MHA disappeared completely in 29 (83%) of 35 patients. Of the remaining 6 patients, 3 patients (8%) had an improvement of ≥2 grades in the incidence and severity of MHA, 2 patients did not show any improvement of their MHA, whereas 1 patient reported a severe relapse of MHA about 1 year after the procedure. Conclusions: In patients with PFO, MHA is associated with spontaneous large R-to-L shunt and thrombophilic conditions. Transcatheter defect closure seems to be an effective and safe means to treat MHA in patients with PFO. © 2006, Mosby, Inc. All rights reserved.

Published
2006

21. Comparison of results of percutaneous closure of patent foramen ovale for paradoxical embolism in patients with versus without thrombophilia

Author

Roberto Formigari, D. Guidetti, Daniela Prandstraller, Gabriele Bronzetti, Alessandro Giardini, Oscar Gaddi, Fernando M. Picchio, Gualtiero Palareti, Marco Bonvicini, Andrea Donti, GIARDINI A, DONTI A, FORMIGARI R, BRONZETTI G, PRANDSTRALLER D, BONVICINI M, PALARETI G, GUIDETTI D, GADDI O, and PICCHIO F.

Subjects
Adult, Male, medicine.medical_specialty, Percutaneous, Heart disease, Adolescent, Foramen secundum, Thrombophilia, Persistent fetal circulation, Heart Septal Defects, Atrial, Paradoxical embolism, Internal medicine, Coagulopathy, Medicine, Humans, Cardiac Surgical Procedures, business.industry, Middle Aged, medicine.disease, Surgery, Patent foramen ovale, Cardiology, Female, Cardiology and Cardiovascular Medicine, business, Embolism, Paradoxical, Follow-Up Studies
Abstract

We investigated the efficacy of transcatheter patent foramen ovale (PFO) closure to prevent recurrent cerebral ischemic events in patients who did and those who did not have thrombophilia. Patients who have a PFO and an associated thrombophilia may have an increased risk of cerebral ischemic events. Seventy-two consecutive patients (mean age 42 +/- 13 years) underwent percutaneous PFO closure because of a cerebral stroke (51%) or a transient ischemic attack (49%). A thrombophilia was found in 20 patients (28%). A large right-to-left shunt through the PFO was found in 44 patients (61%) and an atrial septal aneurysm was found in 39 (54%). After the first event, 18 of 20 patients (90%) with a thrombophilia received oral anticoagulation. Before closure, patients who had a thrombophilia also had a higher rate of recurrences than patients who did not (p0.0001), despite a similar follow-up (p = 0.14) and regardless of shunt entity (p = 0.59), presence of an atrial septal aneurysm (p = 0.98), and a prevalence of cardiovascular risk factors (p = 0.44). PFO closure was successful in all patients. Five patients (8%) had a residual shunt at 6 months. At 20 +/- 11 months after PFO closure, 3 recurrent events occurred (4%), and the recurrence rate was similar in patients who did and those who did not have a thrombophilia (p = 0.25). Thus, in patients who have a cryptogenic stroke, the association of a PFO with a thrombophilia significantly increases the risk of recurrences. Thus, transcatheter PFO closure is effective for preventing recurrences in patients who have a thrombophilia.

Published
2004

22. An Italian case of CADASIL with mutation CGC-TCG in codon 1006, exon 19 Notch3 gene

Author

Rl Mazzei, Davide Nicoli, G De Berti, D. Guidetti, Giovanna Cenacchi, M. Brini, Fl Conforti, Giulio Zuccoli, Bruno Casali, Gianandrea Pasquinelli, Teresa Sprovieri, GUIDETTI D, CASALI B, MAZZEI RL, CENACCHI G, DE BERTI G, ZUCCOLI G, NICOLI D, CONFORTI FL, SPROVIERI T, PASQUINELLI G., and BRINI M

Subjects
Pathology, medicine.medical_specialty, Notch3 gene, Mutation, Missense, CADASIL, Receptors, Cell Surface, Dermatology, medicine.disease_cause, Angiopathy, Leukoencephalopathy, Exon, Proto-Oncogene Proteins, medicine, Missense mutation, Humans, RNA, Messenger, Codon, Receptor, Notch3, Family Health, Mutation, Receptors, Notch, business.industry, Reverse Transcriptase Polymerase Chain Reaction, Brain, General Medicine, Exons, Pseudobulbar palsy, Middle Aged, medicine.disease, Magnetic Resonance Imaging, Psychiatry and Mental health, medicine.anatomical_structure, Dementia, Multi-Infarct, Italy, Cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy, Basal lamina, Female, Neurology (clinical), business
Abstract

Cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL) is commonly overlooked or misdiagnosed owing to its recent identification. It is characterized clinically by recurrent cerebral infarcts, usually appearing between the ages of 30 and 50 years, subcortical dementia, and pseudobulbar palsy. It begins with migraine with aura in approximately one-third of patients. The pathological hallmark of angiopathy is the presence of characteristic granular osmiophilic material (GOM) within the basal lamina of smooth muscle cells. The defective gene in CADASIL is Notch3, which encodes a large transmembrane receptor, and 70% of missense mutations are in exons 3 and 4. Each gene defect leads to either a gain or loss of a cysteine residue in the extracellular N-terminal domain of the molecule. We report the case of a 53-year-old woman admitted to the hospital for transient ischemic attack and stroke-like episodes recurrent since age 43 years. The patient had pseudobulbar palsy, pyramidal signs, and cognitive impairment but not frank dementia. Cerebral MRI showed periventricular diffuse and confluent ischemic lesions. Ultrastructural study revealed an abnormal deposition of granular osmiophilic material (GOM) within the basal lamina in skin capillaries. Direct sequence analysis of the Notch3 gene was performed. Since no mutation was detected in exons 3 and 4, the remaining exons were sequenced and a missense mutation, CGC-TGC in codon 1006 of exon 19 was found. The mutation led to a gain of a cysteine residue. This is the first missense mutation in codon 1006 of exon 19 of the Notch3 gene to be described in Italy and the second reported in the literature.

Published
2003

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