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3. Aspirin and Extended-Release Dipyridamole versus Clopidogrel for Recurrent Stroke

Author

Sacco, Rl, Diener, Hc, Yusuf, S, Cotton, D, Ounpuu, S, Lawton, Wa, Palesch, Y, Martin, Rh, Albers, Gw, Bath, P, Bornstein, N, Chan, Bp, Chen, St, Cunha, L, Dahlöf, B, DE KEYSER, J, Donnan, Ga, Estol, C, Gorelick, P, Gu, V, Hermansson, K, Hilbrich, L, Kaste, M, Lu, C, Machnig, T, Pais, P, Roberts, R, Skvortsova, V, Teal, P, Toni, Danilo, Vandermaelen, C, Voigt, T, Weber, M, Yoon, Bw, Lembo, Giuseppe, Rasura, Maurizia, Sacchetti, Maria Luisa, Faculteit Medische Wetenschappen/UMCG, Gerontology, Department of neurology, University of Miami Leonard M. Miller School of Medicine (UMMSM)-University of Miami [Coral Gables], Universität Duisburg-Essen [Essen], Boehringer Ingelheim GmbH, Boehringer Ingelheim Pharmaceuticals, Population Health Research Institute, McMaster University [Hamilton, Ontario]-Hamilton General Hospital, Boehringer Ingelheim, Boehringer Ingelheim Ltd, Department of biostatistics, Bioinformatics and Epidemiology, Medical University of South Carolina [Charleston] (MUSC), Neurology and Neurological Sciences, Stanford University, Stroke Trials Unit, University of Nottingham, UK (UON), Neurology Department, Ichilov Medical Center, Division of Neurology, Department of Medicine, National University Hospital Singapore, Department of Neurology, Chang Gung Memorial Hospital [Taipei] (CGMH), Neurology department, Universidade de Coimbra [Coimbra], Institute of Medicine, Sahlgrenska University Hospital [Gothenburg], University Medical Center Groningen [Groningen] (UMCG), National Stroke Research Institute, University of Melbourne, Neurological Center for Treatment and Research, Department of Neurology and Rehabilitation, University of Illinois System, Boehringer Ingelheim Shanghai Pharmaceuticals Co Ltd, Boehringer Ingelheim AB, Helsinki University Central Hospital, Huashan Hospital [Shangai], Saint John's Medical College, Clinical Trials Methodoloy Group, McMaster University [Hamilton, Ontario], Neurology & Neurosurgery Clinic, Russian State Medical University, Department of Medicine, Neurology, Faculty of Medicine, University of British Columbia (UBC), Department of Neurological Sciences, Università degli Studi di Roma 'La Sapienza' = Sapienza University [Rome], Cardiology Department, SUNY Downstate Medical Center, State University of New York (SUNY)-State University of New York (SUNY), Seoul National University Hospital, Service de Neurologie [CHU Limoges], CHU Limoges, Neuroépidémiologie Tropicale et Comparée (NETEC), Génomique, Environnement, Immunité, Santé, Thérapeutique (GEIST FR CNRS 3503)-Institut d'Epidémiologie Neurologique et de Neurologie Tropicale-Université de Limoges (UNILIM), Université de Limoges (UNILIM)-Institut d'Epidémiologie Neurologique et de Neurologie Tropicale-Génomique, Environnement, Immunité, Santé, Thérapeutique (GEIST FR CNRS 3503), Sacco, Rl, Diener, Hc, Yusuf, S, Cotton, D, Ounpuu, S, Lawton, Wa, Palesch, Y, Martin, Rh, Albers, Gw, Bath, P, Bornstein, N, Chan, Bp, Chen, St, Cunha, L, Dahlof, B, DE KEYSER, J, Donnan, Ga, Estol, C, Gorelick, P, Gu, V, Hermansson, K, Hilbrich, L, Kaste, M, Lu, C, Machnig, T, Pais, P, Roberts, R, Skvortsova, V, Teal, P, Toni, D, Vandermaelen, C, Voigt, T, Weberm, Yoon, Bw, and Comi, Giancarlo

Subjects
Male, Myocardial Infarction, Angiotensin-Converting Enzyme Inhibitors, MESH: Cognition, Brain Ischemia, NON-INFERIORITY TRIALS, 0302 clinical medicine, aspirina, Secondary Prevention, Aspirin, MESH: Middle Aged, MESH: Risk, Hazard ratio, MESH: Disability Evaluation, MESH: Brain Ischemia, Dipyridamole, MESH: Follow-Up Studies, ARTERIAL ORIGIN ESPRIT, General Medicine, RANDOMIZED CONTROLLED-TRIAL, 3. Good health, MESH: Myocardial Infarction, Platelet aggregation inhibitor, Drug Therapy, Combination, MESH: Hemorrhage, medicine.medical_specialty, MESH: Ticlopidine, MESH: Delayed-Action Preparations, MESH: Drug Delivery Systems, MESH: Factor Analysis, Statistical, Hemorrhage, MESH: Drug Administration Schedule, MESH: Stroke, 03 medical and health sciences, MESH: Severity of Illness Index, Humans, Vascular Diseases, ACTIVE CONTROLLED-TRIALS, MESH: Kaplan-Meier Estimate, Aged, ictus, trial clinico, MESH: Humans, Proportional hazards model, MESH: Angiotensin II Type 1 Receptor Blockers, MESH: Retrospective Studies, medicine.disease, MESH: Benzoates, PREVENTION, MESH: International Cooperation, Delayed-Action Preparations, Benzimidazoles, Factor Analysis, Statistical, MESH: Mental Status Schedule, MESH: Female, 030217 neurology & neurosurgery, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, Benzoates, MESH: Proportional Hazards Models, DOUBLE-BLIND, MESH: Double-Blind Method, Telmisartan, Stroke, MESH: Aged, MESH: Angiotensin-Converting Enzyme Inhibitors, Middle Aged, Clopidogrel, MESH: Platelet Aggregation Inhibitors, Anesthesia, MESH: Vascular Diseases, Cardiology, Female, [SDV.NEU]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC], medicine.drug, Risk, Double-Blind Method, TICLOPIDINE, Internal medicine, medicine, cardiovascular diseases, MESH: Aspirin, Ticlopidine, HIGH-RISK PATIENTS, Proportional Hazards Models, CEREBRAL-ISCHEMIA, business.industry, MESH: Male, MESH: Recurrence, MESH: Drug Therapy, Combination, TRANSIENT ISCHEMIC ATTACK, MESH: Dipyridamole, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, MESH: Benzimidazoles, business, Platelet Aggregation Inhibitors
Abstract

Prevention Regimen for Effectively Avoiding Second Strokes (PRoFESS) trial; International audience; BACKGROUND: Recurrent stroke is a frequent, disabling event after ischemic stroke. This study compared the efficacy and safety of two antiplatelet regimens--aspirin plus extended-release dipyridamole (ASA-ERDP) versus clopidogrel. METHODS: In this double-blind, 2-by-2 factorial trial, we randomly assigned patients to receive 25 mg of aspirin plus 200 mg of extended-release dipyridamole twice daily or to receive 75 mg of clopidogrel daily. The primary outcome was first recurrence of stroke. The secondary outcome was a composite of stroke, myocardial infarction, or death from vascular causes. Sequential statistical testing of noninferiority (margin of 1.075), followed by superiority testing, was planned. RESULTS: A total of 20,332 patients were followed for a mean of 2.5 years. Recurrent stroke occurred in 916 patients (9.0%) receiving ASA-ERDP and in 898 patients (8.8%) receiving clopidogrel (hazard ratio, 1.01; 95% confidence interval [CI], 0.92 to 1.11). The secondary outcome occurred in 1333 patients (13.1%) in each group (hazard ratio for ASA-ERDP, 0.99; 95% CI, 0.92 to 1.07). There were more major hemorrhagic events among ASA-ERDP recipients (419 [4.1%]) than among clopidogrel recipients (365 [3.6%]) (hazard ratio, 1.15; 95% CI, 1.00 to 1.32), including intracranial hemorrhage (hazard ratio, 1.42; 95% CI, 1.11 to 1.83). The net risk of recurrent stroke or major hemorrhagic event was similar in the two groups (1194 ASA-ERDP recipients [11.7%], vs. 1156 clopidogrel recipients [11.4%]; hazard ratio, 1.03; 95% CI, 0.95 to 1.11). CONCLUSIONS: The trial did not meet the predefined criteria for noninferiority but showed similar rates of recurrent stroke with ASA-ERDP and with clopidogrel. There is no evidence that either of the two treatments was superior to the other in the prevention of recurrent stroke. (ClinicalTrials.gov number, NCT00153062.)

Published
2008

4. Telmisartan to prevent recurrent stroke and cardiovascular events

Author

Yusuf, S, Diener, Hc, Sacco, Rl, Cotton, D, Ounpuu, S, Lawton, Wa, Palesch, Y, Martin, Rh, Albers, Gw, Bath, P, Bornstein, N, Chan, Bp, Chen, St, Cunha, L, Dahlöf, B, DE KEYSER, J, Donnan, Ga, Estol, C, Gorelick, P, Gu, V, Hermansson, K, Hilbrich, L, Kaste, M, Lu, C, Machnig, T, Pais, P, Roberts, R, Skvortsova, V, Teal, P, Toni, Danilo, Vandermaelen, C, Voigt, T, Weber, M, Yoon, Bw, Lembo, Giuseppe, Rasura, Maurizia, Sacchetti, Maria Luisa, Hamilton General Hospital, Population Health Research Institute, McMaster University [Hamilton, Ontario]-Hamilton General Hospital, Universität Duisburg-Essen [Essen], Miller School of Medicine, University of Miami [Coral Gables], Institute of Medicine, Sahlgrenska University Hospital, Helsinki University, Institut de Génétique Moléculaire de Montpellier ( IGMM ), Université de Montpellier ( UM ) -Centre National de la Recherche Scientifique ( CNRS ), Neuroépidémiologie Tropicale et Comparée ( NETEC ), Génomique, Environnement, Immunité, Santé, Thérapeutique ( GEIST FR CNRS 3503 ) -Institut d'Epidémiologie Neurologique et de Neurologie Tropicale-Université de Limoges ( UNILIM ), Service de Neurologie [CHU Limoges], CHU Limoges, University of Miami Leonard M. Miller School of Medicine (UMMSM), Sahlgrenska University Hospital [Gothenburg], University of Helsinki, Institut de Génétique Moléculaire de Montpellier (IGMM), Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM), Yusuf, S, Diener, Hc, Sacco, Rl, Cotton, D, Ounpuu, S, Lawton, Wa, Palesch, Y, Martin, Rh, Albers, Gw, Bath, P, Bornstein, N, Chan, Bp, Chen, St, Cunha, L, Dahlof, B, De Keyser, J, Donnan, Ga, Estol, C, Gorelick, P, Gu, V, Hermansson, K, Hilbrich, L, Kaste, M, Lu, C, Machnig, T, Pais, P, Roberts, R, Skvortsova, V, Teal, P, Toni, D, Vandermaelen, C, Voigt, T, Weber, M, Yoon, Bw, Comi, Giancarlo, PRoFESS Stuy, Group, Gerontology, and Faculteit Medische Wetenschappen/UMCG

Subjects
Male, MESH: Treatment Failure, MESH : Recurrence, Myocardial Infarction, MESH : Aged, Angiotensin-Converting Enzyme Inhibitors, Blood Pressure, BLOOD-PRESSURE, 0302 clinical medicine, DESIGN, Secondary Prevention, MESH : Cardiovascular Diseases, Myocardial infarction, MESH: Middle Aged, Hazard ratio, General Medicine, MESH: Follow-Up Studies, MESH: Blood Pressure, 3. Good health, MESH: Myocardial Infarction, MESH : Diabetes Mellitus, Cardiovascular Diseases, Creatinine, MESH : Angiotensin-Converting Enzyme Inhibitors, Ramipril, medicine.medical_specialty, MESH: Diabetes Mellitus, MESH: Creatinine, [ SDV.MHEP.GEG ] Life Sciences [q-bio]/Human health and pathology/Geriatry and gerontology, Article, MESH: Stroke, 03 medical and health sciences, MESH : Treatment Failure, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, Diabetes Mellitus, Humans, MESH : Middle Aged, COMBINATION, MESH: Kaplan-Meier Estimate, Aged, Heart Failure, MESH: Humans, VASCULAR EVENTS, MORTALITY, MESH : Humans, MESH : Creatinine, MESH: Cardiovascular Diseases, MESH : Follow-Up Studies, medicine.disease, MESH: Benzoates, RAMIPRIL, Blood pressure, MESH : Potassium, Potassium, Benzimidazoles, MESH : Heart Failure, MESH: Female, 030217 neurology & neurosurgery, MESH : Stroke, RATIONALE, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, Benzoates, RANDOMIZED TRIAL, DOUBLE-BLIND, MESH : Female, sartani, ictus, trial clinico, Telmisartan, Treatment Failure, Stroke, MESH: Aged, [SDV.MHEP.GEG]Life Sciences [q-bio]/Human health and pathology/Geriatry and gerontology, MESH: Angiotensin-Converting Enzyme Inhibitors, Middle Aged, [ SDV.MHEP.CSC ] Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, MESH : Benzimidazoles, Cardiology, Female, medicine.drug, MESH : Benzoates, MESH : Male, MESH : Kaplan-Meier Estimate, Internal medicine, Diabetes mellitus, medicine, MESH : Blood Pressure, HIGH-RISK PATIENTS, business.industry, Angiotensin II, MESH: Male, Surgery, MESH: Recurrence, MESH: Heart Failure, MESH: Potassium, MESH : Myocardial Infarction, business, MESH: Benzimidazoles, Follow-Up Studies
Abstract

Background: Prolonged lowering of blood pressure after a stroke reduces the risk of recurrent stroke. In addition, inhibition of the renin-angiotensin system in high-risk patients reduces the rate of subsequent cardiovascular events, including stroke. However, the effect of lowering of blood pressure with a renin-angiotensin system inhibitor soon after a stroke has not been clearly established. We evaluated the effects of therapy with an angiotensin-receptor blocker, telmisartan, initiated early after a stroke.Methods: In a multicenter trial involving 20,332 patients who recently had an ischemic stroke, we randomly assigned 10,146 to receive telmisartan (80 mg daily) and 10,186 to receive placebo. The primary outcome was recurrent stroke. Secondary outcomes were major cardiovascular events (death from cardiovascular causes, recurrent stroke, myocardial infarction, or new or worsening heart failure) and new-onset diabetes.Results: The median interval from stroke to randomization was 15 days. During a mean follow-up of 2.5 years, the mean blood pressure was 3.8/2.0 mm Hg lower in the telmisartan group than in the placebo group. A total of 880 patients (8.7%) in the telmisartan group and 934 patients (9.2%) in the placebo group had a subsequent stroke (hazard ratio in the telmisartan group, 0.95; 95% confidence interval [CI], 0.86 to 1.04; P=0.23). Major cardiovascular events occurred in 1367 patients (13.5%) in the telmisartan group and 1463 patients (14.4%) in the placebo group (hazard ratio, 0.94; 95% CI, 0.87 to 1.01; P=0.11). New-onset diabetes occurred in 1.7% of the telmisartan group and 2.1% of the placebo group (hazard ratio, 0.82; 95% CI, 0.65 to 1.04; P=0.10).Conclusions: Therapy with telmisartan initiated soon after an ischemic stroke and continued for 2.5 years did not significantly lower the rate of recurrent stroke, major cardiovascular events, or diabetes. (ClinicalTrials.gov number, NCT00153062.).

Published
2008

5. Prevention Regimen for effectively avoiding second strokes (PRoFESS) study group

Author

DIENER HC, SACCO RL, YUSUF S, COTTON D, OUNPUU S, LAWTON WA, PALESCH Y, MARTIN RH, ALEBRS GW, BATH P, BORNSTEIN N, CHAN BP, CHEN ST, CUNHA L, DAHLOF B, DE KEYSER J, DONNAN GA, ESTOL C, GORELICK P, GU V, TEAL P, TONI D, VANDER MAELEN C, VOIGT T, WEBER M, COMI , GIANCARLO, Diener, Hc, Sacco, Rl, Yusuf, S, Cotton, D, Ounpuu, S, Lawton, Wa, Palesch, Y, Martin, Rh, Alebrs, Gw, Bath, P, Bornstein, N, Chan, Bp, Chen, St, Cunha, L, Dahlof, B, DE KEYSER, J, Donnan, Ga, Estol, C, Gorelick, P, Gu, V, Teal, P, Toni, D, VANDER MAELEN, C, Voigt, T, Weber, M, and Comi, Giancarlo

Published
2008

6. effects of apsirin plus extended-release dipyridamole versus clopidogrel and telmisartan on disability and cognitive function after recurrent stroke in patients with ischaemic stroke in the Prevention regimen for Effectively Avoiding Second Strokes (Profess) trial: a double-bind, active and placebo controled study

Author

YUSUF, S, DIENER HC, SACCO RL, COTTON D, OUNPUU S, LAWTON WA PALESCH Y. MARTIN RH ALBERS GW, BATH P, BORNSTEIN N, CHAN BP, CHEN ST, CUNHA L, DAHLOF B, DE KEYSER J, DONNAN GA, ESTOL C, GORELICK P, GU V, HERMANSSON K, HILBRICH L, KASTE M, LU C, MACHNIG T, PAIS P, ROBERTS R, SKVORTSOVA V, TEAL P, TONI D, VANDERMAELEN C, VOIGT T, WEBER M, YOON BW, COMI , GIANCARLO, Yusuf, S, Diener, Hc, Sacco, Rl, Cotton, D, Ounpuu, S, LAWTON WA PALESCH Y., MARTIN RH ALBERS GW, Bath, P, Bornstein, N, Chan, Bp, Chen, St, Cunha, L, Dahlof, B, DE KEYSER, J, Donnan, Ga, Estol, C, Gorelick, P, Gu, V, Hermansson, K, Hilbrich, L, Kaste, M, Lu, C, Machnig, T, Pais, P, Roberts, R, Skvortsova, V, Teal, P, Toni, D, Vandermaelen, C, Voigt, T, Weber, M, Yoon, Bw, and Comi, Giancarlo

Published
2008

7. Validity of the US Behavioral Risk Factor Surveillance System's health related quality of life survey tool in a group of older Canadians

Author

Ounpuu S, Lw, Chambers, Chan D, and Salim Yusuf

Subjects
Aged, 80 and over, Male, Canada, Health Status, Health Behavior, Age Factors, Infant, Reproducibility of Results, Risk Assessment, United States, Logistic Models, Sex Factors, Population Surveillance, Surveys and Questionnaires, Quality of Life, Health Status Indicators, Humans, Female, Centers for Disease Control and Prevention, U.S, Aged
Abstract

Investigators at the Centers for Disease Control and Prevention in the US have developed a brief survey tool to measure health-related quality of life (HRQOL-4). In order to support use of such tools in surveillance, it is important to assess their validity in different groups. Subjects were 926 non-institutionalized men and women (ageor = 65 years) who completed a health exam and questionnaire. Results indicated that physical and mental health and physical activity limitation were each related to self-perceived health. Compared with subjects who reported excellent health, those with poor self-rated health reported a more than 17-fold increase in the number of unhealthy days in the previous 30. While responses to questions addressing psychosocial factors were most consistently associated with the HRQOL item relating to mental health, responses to health and health behaviour questions were more consistently associated with items related to physical health. This study demonstrated that the HRQOL-4 is not only accepted by older adults in a self-administered format, but also stands up to tests of its validity.

Published
2002

21. Evaluation of the pressure relief ankle foot orthosis in individuals with hemiparesis using three-dimensional gait analysis.

Author

Lin RS, Ounpuu S, Oppedisano MJ, and Kamienski K

Abstract

Application of an ankle foot orthosis (AFO) has proven to be an effective means of improving functional ambulation in the hemiparetic individual. Although many custom-fabricated AFO designs are commonly used to improve different gait parameters, application of the pressure relief AFO (PRAFO) has empirically been shown to offer similar improvements in ambulatory potential in this patient population. Computerized gait analyses of eight hemiparetic patients were conducted for barefoot ambulation and in the PRAFO to compare kinetic and kinematic changes when wearing the PRAFO as a functional orthosis. The data demonstrated statistically significant improvements in the sagittal plane ankle kinematics for all subjects who demonstrated excessive equinus during barefoot ambulation-thus substantiating the observations that the PRAFO can provide effective control of the ankle foot complex during hemiparetic gait. [ABSTRACT FROM AUTHOR]

Published
2009

31. The validity of the 24 hour recall for estimating the energy and selected nutrient intakes of a group of rural Malawian preschool children.

Author

Ferguson, E.L., Gibson, R.S., Ounpuu, S., and Sabry, J.H.

Abstract

The validity of the 24‐hour recall (24 HR) for estimating group aggregate and individual daily energy, protein, calcium, iron, zinc and vitamin C intakes of 29 rural Malawian children (4–6 years) was assessed by comparing weighed record (WR) and 24 HR dietary data collected for the same day of food intake. There were no significant differences comparing group median energy and nutrient intakes estimated using the two techniques. The percentage differences between group mean intakes ranged from 1% (vitamin C) to 16% (Ca). In general, these differences were reduced when morning meal intakes were omitted to eliminate the systematic bias affecting estimates of porridge intake. Spearmans and intra‐class correlation coefficients ranged from 0.28 (vitamic C) to 0.55 (Zn), and from 0.14 (vitamin C) to 0.51 (Zn), respectively. Less than 35% of the nutrient intakes estimated using the 24 HR were within ± 10% of those estimated via the WR (range = 12% for vitamin C and Ca to 33% for protein), and over 50% of the subjects consumed more than ± 20% of the 24 HR estimates for most nutrients. Reasons for the low percentage agreement between the WR and 24 HR results included errors in reporting snack food consumption, the use of average recipes, and imprecision in the recall of quantities of main meal dishes consumed. These data suggest that the 24 HR could be substituted for the WR, when estimates to within ± 10% of actual group mean intakes of energy, protein, iron, and zinc are required. [ABSTRACT FROM PUBLISHER]

Published
1989
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32. Step length reductions in advanced age: the role of ankle and hip kinetics.

Author

Judge, J O, Davis, R B 3rd, and Ounpuu, S

Subjects
PSYCHOLOGICAL aspects of aging, KNEE physiology, ANKLE physiology, COMPARATIVE studies, DYNAMICS, GAIT in humans, RESEARCH methodology, MEDICAL cooperation, POSTURE, RESEARCH, WALKING, EVALUATION research
Abstract

Background: Aging is associated with a reduction in gait velocity, which is due to a shortened step length. This study investigated the relationship between joint kinetics and step length.Methods: Three-dimensional gait kinematics and kinetics were measured during usual pace gait in 26 older subjects (average age 79) and in 32 young subjects (average age 26). Gait measures were obtained at maximal velocity in five older subjects. Lower extremity strength was measured in the older subjects on an isokinetic dynamometer.Results: Older persons had a 10% shorter step length during usual gait, when corrected for leg length (.65 +/- .07, .74 +/- .04/leg length, respectively, p < .001). Older persons had reduced ankle plantarflexion during late stance (13 +/- 5 degrees, 17 +/- 5 degrees, p = .02) and lower ankle plantarflexor power (2.9 +/- 0.9 W kg-1, 3.5 +/- 0.9 W kg-1, respectively, p = .007). Ankle strength was associated with plantarflexor power developed during late stance (r = .49, p < .001). When gait kinetics were corrected for step length, the older subjects developed 16% greater hip flexor power during late stance than younger subjects (estimate of effect: .15 W kg-1, p = .002). Older subjects were unable to increase ankle plantarflexor power at maximal pace, but increased hip flexor power 72% (1.1 +/- 0.3 W kg-1 to 1.9 +/- 1.0 W kg-1, p = .02).Conclusions: Older subjects had lower ankle plantarflexor power during the late stance phase of gait and appeared to compensate for reductions in plantarflexor power by increasing hip flexor power. Appropriate training of ankle plantarflexor muscles may be important in maintaining step length in advanced age. [ABSTRACT FROM AUTHOR]

Published
1996

39. The clopidogrel in unstable angina to prevent Recurrent Events (CURE) trial programme - Rationale, design and baseline characteristics including a meta-analysis of the effects of thienopyridines in vascular disease

Author

Yusuf, S., Mehta, S., Anand, S., Avezum, A., Awan, N., Bertrand, M., Blumenthal, M., Bouthier, J., Budaj, A., Ceremuzynski, L., Chrolavicius, S., Col, J., Commerford, P., Diaz, R., Flather, M., Fox, K., Franzosi, Mg, Gaudin, C., Gersh, B., Grossman, W., Halon, D., Hess, T., Hunt, D., Joyner, C., Karatzas, N., Keltai, M., Khurmi, N., Kopecky, S., Lewis, B., Maggioni, A., Malmberg, K., Moccetti, T., Morais, J., Paolasso, E., Peters, R., Piegas, L., Pipilis, A., Ramos-Corrales, Ma, Rupprecht, Hj, Ryden, L., Sitkei, E., Sotty, M., Tognoni, G., Valentin, V., Varigos, J., Widimsky, P., Wittlinger, T., Pogue, J., Copland, I., Cracknell, B., Demers, C., Eikelboom, J., Hall, K., Keys, J., Mcqueen, M., Montague, P., Morris, B., Ounpuu, S., Wright, C., Yacyshyn, V., Zhao, F., Lewis, Bs, Commerford, Pj, Wyse, G., Cairns, J., Hart, R., Hirsh, J., Gent, M., Ryan, T., Wittes, J., Auger, P., Basart, Dcg, Chan, Y., Raedt, H., Den Hartoog, M., Galli, M., Garcia-Guerrero, Jj, Marquis, Jf, Mauri, F., Mayosi, B., Natarajan, M., Nieminen, M., Norris, J., Panju, A., Peters, Rj, Renkin, J., Rihal, C., Szymanski, P., Wasek, W., Allende, G., Bono, Jo, Caccavo, A., Fernandez, Aa, Fuselli, Jj, Gambarte, Aj, Guerrero, Raa, Hasbani, Eg, Liprandi, As, Marzetti, E., Mon, G., Nordaby, R., Nul, D., Quijano, G., Salvati, A., San Martin, E., Sokn, F., Torre, H., Trivi, M., Tuero, E., Amerena, J., Bailey, N., Bett, Jhn, Buncle, A., Careless, D., Desilva, S., Ewart, A., Fitzpatrick, D., Garrahy, P., Gunawardane, K., Hamer, A., Hill, A., Jackson, B., Lane, G., Nelson, G., Owensby, D., Rees, D., Rosen, D., Sampson, J., Singh, B., Taylor, R., Thomson, A., Walsh, W., Watson, B., Glogar, H., Steinbach, K., Geutjens, L., Ledune, J., Lescot, C., Popeye, R., Vermeulen, J., Abrantes, Ja, Baruzzi, Ac, Bassan, R., Bodanese, Lc, Carvalho, Ac, Mario Coutinho, Albuquerque, Dc, Dutra, O., Esteves, Jp, Leaes, Pe, Marino, Rl, Neto, Jam, Nicolau, Jc, Rabelo, A., Timerman, A., Xavier, Ss, Bata, I., Bhargava, Rk, Bogaty, P., Bolduc, P., Boyne, T., Chan, Yk, D Astous, M., Davies, T., Dhingra, S., Desjardins, L., Douglas, Jg, Fortin, C., Fung, A., Gangbar, E., Gebhardt, V., Gervais, Pb, Giannoccaro, Jp, Gossard, D., Gosselin, G., Grandmont, D., Grover, A., Gupta, M., Hiscock, Jg, Hynd, Jwh, Hussain, M., Iless, A., Kitching, A., Kostuk, W., Kouz, S., Kwok, K., Lee, H., Lefkowitz, C., Lenis, J., Lubelsky, B., Ma, P., May, B., Mercier, M., Montigny, M., Morris, A., Nawaz, S., Pallie, S., Parekh, P., Pesant, Y., Pilon, C., Pistawka, K., Rajakumar, Arj, Rebane, T., Ricci, J., Ruel, M., Schuld, R., Starra, R., Sussex, B., Talbot, P., Theroux, P., Venkatesh, G., Weeks, As, Winkler, Lh, Wisenberg, G., Woo, K., Yu, E., Zadra, R., Bocek, P., Branny, M., Cepelak, V., Drapalik, V., Gregor, P., Groch, L., Jansky, P., Kalslerova, M., Starek, A., Svitil, P., Vaclavicek, A., Husted, S., Rasmussen, Lh, Nielsen, Hk, Hamalainen, T., Majamas-Voltti, K., Mustonen, J., Peuhkurinen, K., Raasakka, T., Ylitalo, A., Adam, 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D'Astous, M, Davies, T, Dhingra, S, Desjardins, L, Douglas, Jg, Fortin, C, Fung, A, Gangbar, E, Gebhardt, V, Gervais, Pb, Giannoccaro, Jp, Gossard, D, Gosselin, G, Grandmont, D, Grover, A, Gupta, M, Hiscock, Jg, Hynd, Jwh, Hussain, M, Iless, A, Kitching, A, Kostuk, W, Kouz, S, Kwok, K, Lee, H, Lefkowitz, C, Lenis, J, Lubelsky, B, Ma, P, May, B, Mercier, M, Montigny, M, Morris, A, Nawaz, S, Pallie, S, Parekh, P, Pesant, Y, Pilon, C, Pistawka, K, Rajakumar, Arj, Rebane, T, Ricci, J, Ruel, M, Schuld, R, Starra, R, Sussex, B, Talbot, P, Theroux, P, Venkatesh, G, Weeks, A, Winkler, Lh, Wisenberg, G, Woo, K, Yu, E, Zadra, R, Bocek, P, Branny, M, Cepelak, V, Drapalik, V, Gregor, P, Groch, L, Jansky, P, Kalslerova, M, Starek, A, Svitil, P, Vaclavicek, A, Husted, S, Rasmussen, Lh, Nielsen, Hk, Hamalainen, T, Majamas Voltti, K, Mustonen, J, Peuhkurinen, K, Raasakka, T, Ylitalo, A, Adam, Mc, Agraou, B, Amat, G, Bessede, G, Boulenc, Jm, Boureux, C, Dambrine, P, Decoulx, E, Delarche, N, Desjoyaux, E, D'Hautefeuille, B, Dubois Rande, Jl, Fadel, N, Fouche, R, Fournier, P, Haftel, Y, Kahn, Jc, Ketelers, Jy, Lallemant, R, Lang, M, Lelguen, C, Leroy, F, Montalescot, G, Poulard, Je, Richard, M, Wittenberg, O, Beythien, Rd, Dippold, Wg, Harenberg, J, Hasslacher, C, Hauptmann, Ke, Hempel, G, Horacek, T, Kaulhausen, A, Kohler, B, Kurz, C, Lengfelder, W, Liebau, G, Loos, U, Neuss, H, Ochs, Hr, Pollock, B, Post, G, Reismann, K, Sauer, M, Schmidt, A, Schmitt, H, Schuster, P, Trenkwalder, P, Uebis, R, von Leitner, Er, Vossbeck, G, Christakos, S, Karidis, K, Kelesidis, K, Papadopoulos, K, Tirologos, A, Tsaknakis, T, Gesztesi, T, Herczeg, B, Janosi, A, Kalo, E, Karpati, P, Mesko, E, Mezofi, M, Poor, F, Regos, L, Rudas, L, Soltesz, P, Szaboki, F, Timar, S, Valyi, P, Zamolyi, K, Daly, Km, Meany, Bt, Sugrue, D, Caspi, A, David, D, Marmor, A, Nazzal, D, Omary, M, Reisin, L, Rosenfeld, T, Shasha, S, Vered, Z, Zimlichman, R, Bellet, C, Bernardi, D, Branzi, A, Ceci, V, Celegon, L, Cernigliaro, C, Corsini, G, Croce, A, De Caterina, R, De Servi, S, Di Biase, G, Di Chiara, A, Di Pasquale, G, Filorizzo, G, Fiorentini, C, Ignone, G, Lombardi, F, Mafrici, A, Margonato, Alberto, Maurea, N, Meneghetti, P, Meniconi, L, Mennuni, M, Mininni, N, Murrone, A, Notaristefan, A, Pettinati, G, Pinelli, G, Rossi, R, Sanna, A, Scabbia, E, Terrosu, P, Trinchero, R, Ruiz, Ra, Diaz, Ac, Santamaria, Ih, Pons, Jll, Diaz, Cj, Castro, Jat, Morales, Ev, Bronzwaer, Pna, de Haan, Hpj, Grosfeld, Mjw, Heijmeriks, Ja, Jochemsen, Gm, Klomps, Hc, Landsaat, Pm, Michels, Hr, Peters, Jrm, van Beek, Gj, van der Hiejden, R, Verheul, Ja, Viergever, Ep, Audeau, M, Bopitiya, U, Hills, M, Ikram, H, Erikssen, J, Morstel, T, Vik Mo, H, Haerem, Jw, Achremczyk, P, Banasiak, W, Burduk, P, Danielewicz, H, Demczuk, M, Dworzanski, W, Frycz, J, Gessek, J, Gorny, J, Janik, K, Jedrzejowski, A, Kawka Urbanek, T, Kozlowski, A, Krasowski, W, Maciejewicz, J, Majcher, Z, Malinowski, S, Marczyk, T, Miekus, P, Ogorek, M, Piepiorka, M, 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Abstract

Background Other than aspirin, there are few oral antithrombotic treatments with proven efficacy in patients with acute coronary syndrome. In this report, we present the rationale, design and baseline characteristics of the Clopidogrel in Unstable angina to prevent Recurrent ischaemic Events (CURE) trial, which includes a meta-analysis of the effects of thienopyridines in patients with vascular disease. Methods and Results Combined data from randomized trials of thienopyrindines in patients with atherosclerotic disease demonstrated a 29% reduction in vascular events when compared with placebo/control (n=2392) (OR 0.71, 95% CI 0.58-0.86, P=0.0006) and a 10% reduction in vascular events when compared with aspirin (n=22 254) (OR 0.91, 95% Cl 0.84-0.99, P=0.039). Similarly, randomized trials of aspirin plus thienopyridines in patients undergoing intracoronary stenting, demonstrated marked benefit of aspirin plus ticlopidine in reducing death or myocardial infarction compared with aspirin alone (OR 0.23, 95% CI 0.11-0.49, P=0.0001) or aspirin plus warfarin (OR 0.51, 95% CI 0.33-0.78, P=0.002). Whether these benefits extend to the much larger population of patients with acute coronary syndrome is unknown. CURE is an international, randomized, double-blind trial, in which patients with acute coronary syndrome will be randomized to receive either a bolus dose of clopidogrel (300 mg) followed by 75 mg per day for 3-12 months, or matching placebo. Both groups will receive aspirin. The co-primary efficacy end-points of CURE are: (1) the composite of cardiovascular death, myocardial infarction or stroke; and (2) the composite of cardiovascular death, myocardial infarction, stroke or refractory ischaemia. CURE will recruit approximately 12 500 patients with acute coronary syndrome (from 28 countries) and its power to detect moderate treatment benefits will be in the region of 80-90%, while maintaining an overall type I error (a) of 0.05. The baseline characteristics of the study population are consistent with at least a moderate risk group of patients with acute coronary syndrome. Conclusions Randomized trials of thienopyridines in patients with vascular disease demonstrate that thienopyridines are effective in reducing vascular events when compared with placebo/control or aspirin, as well as when used in combination with aspirin in patients undergoing intracoronary stent implantation. The CURE trial is a large international study to determine if acute and longterm treatment with the combination of clopidogrel and aspirin is superior to aspirin alone in patients with acute coronary syndrome. (C) 2000 The European Society of Cardiology. RI Nicolau, Jose/E-1487-2012

40. An evaluation of door to needle time (DNT) of thrombolytic therapy following acute myocardial infarction in three large tertiary referral hospitals in Dhaka City

Author

Ma, Muqueet, Km, Sirajul Haque, Gm, Faruque, Hossain M, Rj, Khan, Mahmood M, Ounpuu S, and Salim Yusuf

Subjects
Bangladesh, Time Factors, Surveys and Questionnaires, Acute Disease, Myocardial Infarction, Humans, Thrombolytic Therapy, Prospective Studies, Efficiency, Organizational, Emergency Service, Hospital
Abstract

This study was conducted in three tertiary hospitals in Dhaka city at Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka Medical College Hospital (DMCH) and National Institute of Cardiovascular Disease (NICVD) as a part of Inter-Heart Study. Secondary data was obtained from the standard questionnaires to determine door to needle time (DNT) following thrombolytic therapy in patients with Acute Myocardial Infarction (AMI) in coronary care units at three large tertiary referral hospitals in Dhaka city. Of total 192 patients studied in three centres, 156 (81.2%) received thrombolytic therapy. In BSMMU, 33 out of 45 (73.33%) patients received thrombolysis. Mean DNT was 147 minutes. Eighteen (55%) patients received thrombolysis within 90 minutes and 9 patients (27%) received with in 91-180 minutes, 6 patients (18%) received thrombolysis after 180 minutes. In DMCH, 44 out of 57 patients (77.1%) received thrombolysis. Mean DNT was 210 minutes. Five patients (11%) received within 90 minutes, 19 (43%) received thrombolysis between 91 to 180 minutes and 20 patients (46%) received thrombolysis outside the range of 180 minutes. In the NICVD, 79 out of total 90 (87.7%) patients received thrombolysis. Mean DTN was 64 minutes. Sixty seven (82%) patients received therapy within 90 minutes, 6 patients (9%) received between thrombolysis 91-180 minutes and 6 (9%) patients received after 180 minutes of reaching hospital. Inspite of overall improvement in the management of patients with AMI in coronary care units of major teaching hospitals, there seem to remain certain difficulty in our system which causes delay in thrombolysing patients with AMI. In this study, the mean DNT for thrombolysis was quickest (64 minutes) at NICVD and slowest (210 minutes) at DMCH. Although the study was conducted almost four years ago, it gives some insight regarding strength and weaknesses in the infrastructure of public sector hospitals in our country.

46. ThreeDimensional Lower Extremity Joint Kinetics in Normal Pediatric Gait

Author

Ounpuu, S., Gage, J. R., and Davis, R. B.

Abstract

Gait analysis is becoming a more integral part of the decisionmaking process in treatment of children with neuromuscular problems. A normal reference, however, must be available for comparison when one makes decisions. We wished to develop a normal pediatric database for joint kinematics and kinetics which could then be used as a reference for clinical gait analysis. Thirtyone normal children underwent a complete gait analysis including calculations of threedimensional joint kinematics and kinetics. The pediatric data were similar to that of normal adults.

Published
1991

47. CARDIOVASULAR RISK FACTORS SIMILAR WORLDWIDE.

Author

A. S. Yusuf, Hawken, S., and Ounpuu, S.

Subjects
*CARDIOVASCULAR diseases, *FOOD, *DIET, *HEART disease risk factors, *NUTRITION, *MYOCARDIAL infarction
Abstract

This article focuses on nutrition and cardiovascular diseases. While cardiovascular death rates have declined in most developed countries in the past decades, rates of cardiovascular disease have grown in low-income and middle-income countries. It is estimated that 80% of the burden of cardiovascular disease lies in these less-developed countries. Research and knowledge surrounding the disease have mainly been derived from studies done in populations of European origin. The current report focuses on the association of nine easily measured protective or risk factors, including smoking, lipids, self-reported hypertension or diabetes, obesity, diet, physical activity, alcohol consumption and psychosocial factors, to first myocardial infarction.

Published
2004

49. Is a Three-component Video-based Version of the Foot Posture Index Valid for Assessing Pediatric Patients With Orthopaedic and Neurologic Foot Conditions?

Author

Rethlefsen SA, Ounpuu S, Rodriguez-MacClintic J, Hanson A, Ciccodicola EM, Pierz KA, and Wren TAL

Subjects
Humans, Male, Female, Child, Retrospective Studies, Reproducibility of Results, Adolescent, Posture, Foot Deformities physiopathology, Supination physiology, Observer Variation, Severity of Illness Index, Physical Examination methods, Child, Preschool, Biomechanical Phenomena, Age Factors, Video Recording, Foot physiopathology, Pronation physiology, Predictive Value of Tests
Abstract

Background: The Foot Posture Index-6 (FPI6) is an assessment of foot position that can be useful for patients with orthopaedic complaints. The FPI6 rates six components of foot position from -2 to +2, resulting in a total score on a continuum between -12 (severe cavus or supination) to +12 (severe planus or pronation). The subscores are ratings made by the examiner and are subjective assessments of deformity severity. The FPI6 requires palpation of bony structures around the foot and therefore must be administered live during physical examination. Because it is sometimes impractical to perform these assessments live, such as for retrospective research, a valid and reliable video-based tool would be very useful., Questions/purposes: This study examines a version of the FPI using three of the original six components to determine: (1) Are scores from the three-component version of the FPI (FPI3) associated with those from the original six-component version (FPI6)? (2) Is the three-component FPI3 as reliable as the original six-component FPI6? (3) Are FPI3 assessments done retrospectively from video as reliable as those done live?, Methods: A retrospective group of 155 participants (106 males; mean age 13 ± 4 years) was studied. All had undergone gait analysis including videotaping and in-person assessment using the FPI6. Ratings for three components (calcaneus inversion/eversion, medial arch congruence, and forefoot abduction/adduction) were extracted yielding an FPI3 score ranging from -6 to +6. The other three components of the FPI6 (talar head palpation, curves above and below the lateral malleolus, talonavicular joint bulge) were excluded from the FPI3. FPI6 and FPI3 scores and side-to-side asymmetry were compared for all participants and for diagnosis subgroups (cerebral palsy and Charcot-Marie-Tooth disease) using a Pearson correlation. Agreement for foot posture categorization between the FPI6 and FPI3 was assessed using weighted kappa. Intra- and interrater reliability of live and video-based assessments for the FPI3 and its components were examined using intraclass correlation coefficients (ICCs) and Bland-Altman analysis., Results: Scores from the FPI3 and FPI6 are highly associated with each other, suggesting the FPI3 is an adequate substitute for the FPI6. FPI6 and FPI3 scores (r = 0.98) and asymmetry (r = 0.96) were highly correlated overall and within the cerebral palsy (r = 0.98 for scores; r = 0.98 for asymmetry) and Charcot-Marie-Tooth (r = 0.96 for scores; r = 0.90 for asymmetry) subgroups (all p < 0.001). Agreement between the FPI6 and FPI3 was high for foot posture categorization (weighted agreement = 95%, weighted κ = 0.88; p < 0.001). Interrater reliability for live ratings was similar for FPI3 and FPI6 and high for both measures (ICC = 0.95 for FPI6 and 0.94 for FPI3; both p < 0.001). High reliability was seen in video versus live ratings for the FPI3 total score and each of its components regardless of whether they were performed by the same (ICC = 0.98) or different (ICC = 0.97) raters (both p < 0.001), and interrater reliability remained high when the FPI3 was scored from video recordings (ICC = 0.96; p < 0.001)., Conclusion: The FPI3 is valid and reliable when done live or from video or by the same or different examiners. It is suitable for retrospective and multicenter research studies, provided videos are done using standardized protocols. Further research is recommended investigating possible ceiling and floor effects in patients with pathologic conditions.Level of Evidence Level III, diagnostic study., Competing Interests: Each author certifies that there are no funding or commercial associations (consultancies, stock ownership, equity interest, patent/licensing arrangements, etc.) that might pose a conflict of interest in connection with the submitted article related to the author or any immediate family members. All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research® editors and board members are on file with the publication and can be viewed on request., (Copyright © 2024 by the Association of Bone and Joint Surgeons.)

Published
2024
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50. Comparison of Pain Characteristics, Strength, and Movement Patterns in Adolescents With Juvenile Fibromyalgia and High Versus Low Fear of Movement.

Author

Kashikar-Zuck S, Thomas S, Bonnette S, Gibler RC, DiCesare C, Schille A, Hulburt T, Briggs MS, Ounpuu S, and Myer GD

Subjects
Humans, Female, Adolescent, Male, Muscle Strength physiology, Pain Measurement, Fatigue physiopathology, Fatigue etiology, Kinesiophobia, Fibromyalgia physiopathology, Fibromyalgia psychology, Fear physiology, Movement physiology, Catastrophization physiopathology, Catastrophization psychology
Abstract

Physical activity avoidance and fear of movement (FOM) is often observed in individuals with chronic musculoskeletal pain, along with difficulties coping with pain. There is little research regarding how FOM may also relate to reduced physical strength and altered movement patterns that may perpetuate a cycle of pain, FOM, and disability. The objective of this observational study was to compare how adolescents with juvenile fibromyalgia (JFM) exhibiting high versus low FOM (Tampa Scale of Kinesiophobia-11) differed on patient-reported measures of pain, fatigue, catastrophizing and pain interference, and performance-based measures of strength, postural control, and biomechanical function. Participants were youth with JFM (N = 135, Mean age = 15.6 years, 88.9% female) enrolled in an ongoing clinical trial who completed self-report questionnaires and standardized tests, including knee and hip strength, the Star Excursion Balance Test, and the Drop Vertical Jump (with 3 dimensional motion capture). Participants were categorized into Low, Medium, and High FOM groups based on Tampa Scale of Kinesiophobia-11 tertile scores. Relative to the Low FOM group, the High FOM group reported significantly greater fatigue, pain interference and catastrophizing, as well as reduced dominant leg knee strength. Additionally, those with high FOM showed altered lower-extremity movement patterns. This preliminary study highlights the importance of combining self-reported measures of symptoms and functioning with physical assessments to gain a more comprehensive view of the impact of FOM in patients with chronic musculoskeletal pain. The results could inform the development of more precise interventions to reduce FOM using a combination of behavioral and exercise-based interventions., Perspective: The results of this study demonstrate the association between FOM, fatigue and pain interference in adolescents with JFM, as well as preliminary evidence for altered movement patterns in that may predispose them to further pain/injury and activity avoidance., Gov Registration: NCT03268421., (Copyright © 2024 United States Association for the Study of Pain, Inc. Published by Elsevier Inc. All rights reserved.)

Published
2024
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