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3. Rationale and design of the CV-PREVITAL study: an Italian multiple cohort randomised controlled trial investigating innovative digital strategies in primary cardiovascular prevention

Author

Baldassarre, D, Iacoviello, L, Baetta, R, Roncaglioni, M, Condorelli, G, Remuzzi, G, Gensini, G, Frati, L, Ricciardi, W, Conaldi, P, Uccelli, A, Blandini, F, Bosari, S, Scambia, G, Fini, M, Di Malta, A, Amato, M, Veglia, F, Bonomi, A, Klersy, C, Colazzo, F, Pengo, M, Gorini, F, Auteri, L, Ferrante, G, Baviera, M, Ambrosio, G, Catapano, A, Gialluisi, A, Malavazos, A, Castelvecchio, S, Corsi-Romanelli, M, Cardani, R, La Rovere, M, Agnese, V, Pane, B, Prati, D, Spinardi, L, Liuzzo, G, Arbustini, E, Volterrani, M, Visconti, M, Werba, J, Genovese, S, Bilo, G, Invitti, C, Di Blasio, A, Lombardi, C, Faini, A, Rosa, D, Ojeda-Fernandez, L, Foresta, A, De Curtis, A, Di Castelnuovo, A, Scalvini, S, Pierobon, A, Gorini, A, Valenti, L, Luzi, L, Racca, A, Bandi, M, Tremoli, E, Menicanti, L, Parati, G, Pompilio, G, Colombo, G, Vavassori, C, Biondi, M, Frigerio, B, Ravani, A, Sansaro, D, Coggi, D, Romandini, A, Giroli, M, Giuliani, M, Bonmi, A, Rondinelli, M, Trudu, C, Cinieri, C, Monturano, M, Colazo, F, Inviti, C, Di Blasi, A, Torlasco, C, Gilardini, L, Soranna, D, Zambon, A, Perger, E, Zanotti, L, Badano, L, Cova, L, Gentilini, D, Grappiolo, L, Condoreli, G, Ferante, G, Papa, L, Savevski, V, Ieva, F, Romano, I, Remzzi, G, Ojeda, L, Clerici, F, Palumbo, A, Genini, G, Catpano, A, Mattioli, R, Longhi, E, Mantovani, L, Madotto, F, Bonaccio, M, Gianfagna, F, Ghulam, A, Magnacca, S, Noro, F, Costanzo, S, Esposito, S, Orlandi, S, Persichillo, M, Bracone, F, Panzera, T, Ruggiero, E, Parisi, R, Franciosa, S, Morelli, M, De Rita, F, Cerletti, C, de Gaetano, G, Donati, M, Mencanti, L, Romanelli, M, Cerri, A, Dubini, C, Trevisan, M, Renna, L, Milani, V, Boveri, S, Giubbilini, P, Ramputi, L, Baroni, I, De Angeli, G, Riciardi, W, Olmetti, F, Bussotti, M, Gaetano, C, Baiardi, P, Bachetti, T, Balbi, M, Comini, L, Lorenzoni, M, Olivares, A, Traversi, E, Garre, C, Sideri, R, Clemenza, F, Gentile, G, Caruana, G, Cuscino, N, Di Gesaro, G, Greco, A, Loddo, I, Tuzzolino, F, Ucelli, A, Palombo, D, Spinella, G, Mozzetta, G, Ameri, P, Zoppoli, G, Finotello, A, Porto, I, Pratesi, G, Bladini, F, Spnardi, L, Clerici, M, Pelusi, S, Bianco, C, Carpani, R, Periti, G, Margarita, S, Lanza, G, Severino, A, Pedicino, D, D'Amario, D, D'Aiello, A, Vinci, R, Bonanni, A, Brecciaroli, M, Filomia, S, Pastorino, R, Boccia, S, Urbani, A, Sanguinetti, M, Santoliquido, A, Proto, L, Tarquini, D, Grimaldi, M, Leonardi, S, Elia, A, Currao, A, Urtis, M, Di Toro, A, Giuliani, L, Caminiti, G, Marcolongo, F, Sposato, B, Guadagni, F, Morsella, V, Marziale, A, Protti, G, Baldassarre D., Iacoviello L., Baetta R., Roncaglioni M. C., Condorelli G., Remuzzi G., Gensini G., Frati L., Ricciardi W., Conaldi P. G., Uccelli A., Blandini F., Bosari S., Scambia G., Fini M., Di Malta A., Amato M., Veglia F., Bonomi A., Klersy C., Colazzo F., Pengo M., Gorini F., Auteri L., Ferrante G., Baviera M., Ambrosio G., Catapano A., Gialluisi A., Malavazos A. E., Castelvecchio S., Corsi-Romanelli M. M., Cardani R., La Rovere M. T., Agnese V., Pane B., Prati D., Spinardi L., Liuzzo G., Arbustini E., Volterrani M., Visconti M., Werba J. P., Genovese S., Bilo G., Invitti C., Di Blasio A., Lombardi C., Faini A., Rosa D., Ojeda-Fernandez L., Foresta A., De Curtis A., Di Castelnuovo A., Scalvini S., Pierobon A., Gorini A., Valenti L., Luzi L., Racca A., Bandi M., Tremoli E., Menicanti L., Parati G., Pompilio G., Colombo G., Vavassori C., Biondi M. L., Frigerio B., Ravani A., Sansaro D., Coggi D., Romandini A., Giroli M., Giuliani M., Bonmi A., Rondinelli M., Trudu C., Cinieri C., Monturano M., Colazo F., Inviti C., Di Blasi A., Torlasco C., Gilardini L., Soranna D., Zambon A., Perger E., Zanotti L., Badano L., Cova L., Gentilini D., Grappiolo L., Condoreli G., Ferante G., Papa L., Savevski V., Ieva F., Romano I., Remzzi G., Ojeda L., Clerici F., Palumbo A., Genini G. F., Catpano A., Mattioli R., Longhi E., Mantovani L. G., Madotto F., Bonaccio M., Gianfagna F., Ghulam A., Magnacca S., Noro F., Costanzo S., Esposito S., Orlandi S., Persichillo M., Bracone F., Panzera T., Ruggiero E., Parisi R., Franciosa S., Morelli M., De Rita F., Cerletti C., de Gaetano G., Donati M. B., Mencanti L., Romanelli M. M. C., Cerri A., Dubini C., Trevisan M. B., Renna L. V., Milani V., Boveri S., Giubbilini P., Ramputi L., Baroni I., De Angeli G., Riciardi W., Olmetti F., Bussotti M., Gaetano C., Baiardi P., Bachetti T., Balbi M., Comini L., Lorenzoni M., Olivares A., Traversi E., Garre C., Sideri R., Clemenza F., Gentile G., Caruana G., Cuscino N., Di Gesaro G., Greco A., Loddo I., Tuzzolino F., Ucelli A., Palombo D., Spinella G., Mozzetta G., Ameri P., Zoppoli G., Finotello A., Porto I., Pratesi G., Bladini F., Spnardi L., Clerici M., Pelusi S., Bianco C., Carpani R., Periti G., Margarita S., Lanza G. A., Severino A., Pedicino D., D'Amario D., D'Aiello A., Vinci R., Bonanni A., Brecciaroli M., Filomia S., Pastorino R., Boccia S., Urbani A., Sanguinetti M., Santoliquido A., Proto L., Tarquini D., Grimaldi M. C., Leonardi S., Elia A., Currao A., Urtis M., Di Toro A., Giuliani L., Caminiti G., Marcolongo F., Sposato B., Guadagni F., Morsella V., Marziale A., Protti G., Baldassarre, D, Iacoviello, L, Baetta, R, Roncaglioni, M, Condorelli, G, Remuzzi, G, Gensini, G, Frati, L, Ricciardi, W, Conaldi, P, Uccelli, A, Blandini, F, Bosari, S, Scambia, G, Fini, M, Di Malta, A, Amato, M, Veglia, F, Bonomi, A, Klersy, C, Colazzo, F, Pengo, M, Gorini, F, Auteri, L, Ferrante, G, Baviera, M, Ambrosio, G, Catapano, A, Gialluisi, A, Malavazos, A, Castelvecchio, S, Corsi-Romanelli, M, Cardani, R, La Rovere, M, Agnese, V, Pane, B, Prati, D, Spinardi, L, Liuzzo, G, Arbustini, E, Volterrani, M, Visconti, M, Werba, J, Genovese, S, Bilo, G, Invitti, C, Di Blasio, A, Lombardi, C, Faini, A, Rosa, D, Ojeda-Fernandez, L, Foresta, A, De Curtis, A, Di Castelnuovo, A, Scalvini, S, Pierobon, A, Gorini, A, Valenti, L, Luzi, L, Racca, A, Bandi, M, Tremoli, E, Menicanti, L, Parati, G, Pompilio, G, Colombo, G, Vavassori, C, Biondi, M, Frigerio, B, Ravani, A, Sansaro, D, Coggi, D, Romandini, A, Giroli, M, Giuliani, M, Bonmi, A, Rondinelli, M, Trudu, C, Cinieri, C, Monturano, M, Colazo, F, Inviti, C, Di Blasi, A, Torlasco, C, Gilardini, L, Soranna, D, Zambon, A, Perger, E, Zanotti, L, Badano, L, Cova, L, Gentilini, D, Grappiolo, L, Condoreli, G, Ferante, G, Papa, L, Savevski, V, Ieva, F, Romano, I, Remzzi, G, Ojeda, L, Clerici, F, Palumbo, A, Genini, G, Catpano, A, Mattioli, R, Longhi, E, Mantovani, L, Madotto, F, Bonaccio, M, Gianfagna, F, Ghulam, A, Magnacca, S, Noro, F, Costanzo, S, Esposito, S, Orlandi, S, Persichillo, M, Bracone, F, Panzera, T, Ruggiero, E, Parisi, R, Franciosa, S, Morelli, M, De Rita, F, Cerletti, C, de Gaetano, G, Donati, M, Mencanti, L, Romanelli, M, Cerri, A, Dubini, C, Trevisan, M, Renna, L, Milani, V, Boveri, S, Giubbilini, P, Ramputi, L, Baroni, I, De Angeli, G, Riciardi, W, Olmetti, F, Bussotti, M, Gaetano, C, Baiardi, P, Bachetti, T, Balbi, M, Comini, L, Lorenzoni, M, Olivares, A, Traversi, E, Garre, C, Sideri, R, Clemenza, F, Gentile, G, Caruana, G, Cuscino, N, Di Gesaro, G, Greco, A, Loddo, I, Tuzzolino, F, Ucelli, A, Palombo, D, Spinella, G, Mozzetta, G, Ameri, P, Zoppoli, G, Finotello, A, Porto, I, Pratesi, G, Bladini, F, Spnardi, L, Clerici, M, Pelusi, S, Bianco, C, Carpani, R, Periti, G, Margarita, S, Lanza, G, Severino, A, Pedicino, D, D'Amario, D, D'Aiello, A, Vinci, R, Bonanni, A, Brecciaroli, M, Filomia, S, Pastorino, R, Boccia, S, Urbani, A, Sanguinetti, M, Santoliquido, A, Proto, L, Tarquini, D, Grimaldi, M, Leonardi, S, Elia, A, Currao, A, Urtis, M, Di Toro, A, Giuliani, L, Caminiti, G, Marcolongo, F, Sposato, B, Guadagni, F, Morsella, V, Marziale, A, Protti, G, Baldassarre D., Iacoviello L., Baetta R., Roncaglioni M. C., Condorelli G., Remuzzi G., Gensini G., Frati L., Ricciardi W., Conaldi P. G., Uccelli A., Blandini F., Bosari S., Scambia G., Fini M., Di Malta A., Amato M., Veglia F., Bonomi A., Klersy C., Colazzo F., Pengo M., Gorini F., Auteri L., Ferrante G., Baviera M., Ambrosio G., Catapano A., Gialluisi A., Malavazos A. E., Castelvecchio S., Corsi-Romanelli M. M., Cardani R., La Rovere M. T., Agnese V., Pane B., Prati D., Spinardi L., Liuzzo G., Arbustini E., Volterrani M., Visconti M., Werba J. P., Genovese S., Bilo G., Invitti C., Di Blasio A., Lombardi C., Faini A., Rosa D., Ojeda-Fernandez L., Foresta A., De Curtis A., Di Castelnuovo A., Scalvini S., Pierobon A., Gorini A., Valenti L., Luzi L., Racca A., Bandi M., Tremoli E., Menicanti L., Parati G., Pompilio G., Colombo G., Vavassori C., Biondi M. L., Frigerio B., Ravani A., Sansaro D., Coggi D., Romandini A., Giroli M., Giuliani M., Bonmi A., Rondinelli M., Trudu C., Cinieri C., Monturano M., Colazo F., Inviti C., Di Blasi A., Torlasco C., Gilardini L., Soranna D., Zambon A., Perger E., Zanotti L., Badano L., Cova L., Gentilini D., Grappiolo L., Condoreli G., Ferante G., Papa L., Savevski V., Ieva F., Romano I., Remzzi G., Ojeda L., Clerici F., Palumbo A., Genini G. F., Catpano A., Mattioli R., Longhi E., Mantovani L. G., Madotto F., Bonaccio M., Gianfagna F., Ghulam A., Magnacca S., Noro F., Costanzo S., Esposito S., Orlandi S., Persichillo M., Bracone F., Panzera T., Ruggiero E., Parisi R., Franciosa S., Morelli M., De Rita F., Cerletti C., de Gaetano G., Donati M. B., Mencanti L., Romanelli M. M. C., Cerri A., Dubini C., Trevisan M. B., Renna L. V., Milani V., Boveri S., Giubbilini P., Ramputi L., Baroni I., De Angeli G., Riciardi W., Olmetti F., Bussotti M., Gaetano C., Baiardi P., Bachetti T., Balbi M., Comini L., Lorenzoni M., Olivares A., Traversi E., Garre C., Sideri R., Clemenza F., Gentile G., Caruana G., Cuscino N., Di Gesaro G., Greco A., Loddo I., Tuzzolino F., Ucelli A., Palombo D., Spinella G., Mozzetta G., Ameri P., Zoppoli G., Finotello A., Porto I., Pratesi G., Bladini F., Spnardi L., Clerici M., Pelusi S., Bianco C., Carpani R., Periti G., Margarita S., Lanza G. A., Severino A., Pedicino D., D'Amario D., D'Aiello A., Vinci R., Bonanni A., Brecciaroli M., Filomia S., Pastorino R., Boccia S., Urbani A., Sanguinetti M., Santoliquido A., Proto L., Tarquini D., Grimaldi M. C., Leonardi S., Elia A., Currao A., Urtis M., Di Toro A., Giuliani L., Caminiti G., Marcolongo F., Sposato B., Guadagni F., Morsella V., Marziale A., and Protti G.

Abstract

Introduction Prevention of cardiovascular disease (CVD) is of key importance in reducing morbidity, disability and mortality worldwide. Observational studies suggest that digital health interventions can be an effective strategy to reduce cardiovascular (CV) risk. However, evidence from large randomised clinical trials is lacking. Methods and analysis The CV-PREVITAL study is a multicentre, prospective, randomised, controlled, open-label interventional trial designed to compare the effectiveness of an educational and motivational mobile health (mHealth) intervention versus usual care in reducing CV risk. The intervention aims at improving diet, physical activity, sleep quality, psycho-behavioural aspects, as well as promoting smoking cessation and adherence to pharmacological treatment for CV risk factors. The trial aims to enrol approximately 80 000 subjects without overt CVDs referring to general practitioners' offices, community pharmacies or clinics of Scientific Institute for Research, Hospitalization and Health Care (Italian acronym IRCCS) affiliated with the Italian Cardiology Network. All participants are evaluated at baseline and after 12 months to assess the effectiveness of the intervention on short-term endpoints, namely improvement in CV risk score and reduction of major CV risk factors. Beyond the funded life of the study, a long-term (7 years) follow-up is also planned to assess the effectiveness of the intervention on the incidence of major adverse CV events. A series of ancillary studies designed to evaluate the effect of the mHealth intervention on additional risk biomarkers are also performed. Ethics and dissemination This study received ethics approval from the ethics committee of the coordinating centre (Monzino Cardiology Center; R1256/20-CCM 1319) and from all other relevant IRBs and ethics committees. Findings are disseminated through scientific meetings and peer-reviewed journals and via social media. Partners are informed about the study's

Published
2023

6. Alcohol intake and total mortality in 142 960 individuals from the MORGAM Project: a population-based study

Author

Di Castelnuovo, A, Costanzo, S, Bonaccio, M, Mcelduff, P, Linneberg, A, Salomaa, V, Mannisto, S, Moitry, M, Ferrieres, J, Dallongeville, J, Thorand, B, Brenner, H, Ferrario, M, Veronesi, G, Pettenuzzo, E, Tamosiunas, A, Njolstad, I, Drygas, W, Nikitin, Y, Soderberg, S, Kee, F, Grassi, G, Westermann, D, Schrage, B, Dabboura, S, Zeller, T, Kuulasmaa, K, Blankenberg, S, Donati, M, de Gaetano, G, Iacoviello, L, Di Castelnuovo A., Costanzo S., Bonaccio M., McElduff P., Linneberg A., Salomaa V., Mannisto S., Moitry M., Ferrieres J., Dallongeville J., Thorand B., Brenner H., Ferrario M., Veronesi G., Pettenuzzo E., Tamosiunas A., Njolstad I., Drygas W., Nikitin Y., Soderberg S., Kee F., Grassi G., Westermann D., Schrage B., Dabboura S., Zeller T., Kuulasmaa K., Blankenberg S., Donati M. B., de Gaetano G., Iacoviello L., Di Castelnuovo, A, Costanzo, S, Bonaccio, M, Mcelduff, P, Linneberg, A, Salomaa, V, Mannisto, S, Moitry, M, Ferrieres, J, Dallongeville, J, Thorand, B, Brenner, H, Ferrario, M, Veronesi, G, Pettenuzzo, E, Tamosiunas, A, Njolstad, I, Drygas, W, Nikitin, Y, Soderberg, S, Kee, F, Grassi, G, Westermann, D, Schrage, B, Dabboura, S, Zeller, T, Kuulasmaa, K, Blankenberg, S, Donati, M, de Gaetano, G, Iacoviello, L, Di Castelnuovo A., Costanzo S., Bonaccio M., McElduff P., Linneberg A., Salomaa V., Mannisto S., Moitry M., Ferrieres J., Dallongeville J., Thorand B., Brenner H., Ferrario M., Veronesi G., Pettenuzzo E., Tamosiunas A., Njolstad I., Drygas W., Nikitin Y., Soderberg S., Kee F., Grassi G., Westermann D., Schrage B., Dabboura S., Zeller T., Kuulasmaa K., Blankenberg S., Donati M. B., de Gaetano G., and Iacoviello L.

Abstract

Aim: To test the association of alcohol consumption with total and cause-specific mortality risk. Design: Prospective observational multi-centre population-based study. Setting: Sixteen cohorts (15 from Europe) in the MOnica Risk, Genetics, Archiving and Monograph (MORGAM) Project. Participants: A total of 142 960 individuals (mean age 50 ± 13 years, 53.9% men). Measurements: Average alcohol intake by food frequency questionnaire, total and cause-specific mortality. Findings: In comparison with life-time abstainers, consumption of alcohol less than 10 g/day was associated with an average 11% [95% confidence interval (CI) = 7–14%] reduction in the risk of total mortality, while intake > 20 g/day was associated with a 13% (95% CI = 7–20%) increase in the risk of total mortality. Comparable findings were observed for cardiovascular (CV) deaths. With regard to cancer, drinking up to 10 g/day was not associated with either mortality risk reduction or increase, while alcohol intake > 20 g/day was associated with a 22% (95% CI = 10–35%) increased risk of mortality. The association of alcohol with fatal outcomes was similar in men and women, differed somewhat between countries and was more apparent in individuals preferring wine, suggesting that benefits may not be due to ethanol but other ingredients. Mediation analysis showed that high-density lipoprotein cholesterol explained 2.9 and 18.7% of the association between low alcohol intake and total as well as CV mortality, respectively. Conclusions: In comparison with life-time abstainers, consuming less than one drink per day (nadir at 5 g/day) was associated with a reduced risk of total, cardiovascular and other causes mortality, except cancer. Intake of more than two drinks per day was associated with an increased risk of total, cardiovascular and especially cancer mortality.

Published
2022

7. Economic hardship from the great recession and long-term changes in depression and quality of life

Author

Bonaccio, Marialaura, Costanzo, S., Di Castelnuovo, A., Gialluisi, A., Bracone, F., Persichillo, M., Cerletti, C., Donati, M. B., Gaetano, G., and Licia Iacoviello

Subjects
Public Health, Environmental and Occupational Health
Abstract

Background Economic downturns may have detrimental effects on mental health. We investigated whether economic hardship resulting from the late 2000s great recession is associated with long-term changes in mental health over 12.8 years of follow up. Methods We analysed data on 2,001 participants from the CASSIOPEA Study, a sub-cohort of the larger Moli-sani study (2005-2010, Italy), who were re-examined between 2017-2020 (mean age at baseline 53±9 y; 55% women). Economic hardship possibly experienced since participants' first visit was assessed retrospectively by a questionnaire scoring the following domains: 1) change in employment status; 2) financial hardship and 3) financial hardship for health expenditures. An Economic Hardship Score (EHS) was computed (range 0-14), with highest values indicating higher economic hardship. Mental health was reflected by measurements of depression (Patients' Health Questionnaire; PHQ-2; higher values indicating more depressive symptoms) and mental quality of life assessed by the 36-Item Short Form Health Survey (increased values indicating improved quality of life). In this analysis, the exposure was economic hardship and the outcomes were changes in depression and mental quality of life measured after a 12.8-y period. Multivariable linear regression analysis (95%CI) was used. Results Mean PHQ-2 and SF36 changes over 12.8 years were -0.08 (±1.28) and 0.47 (±9.90), respectively. In a multivariable-adjusted analysis including duration of follow-up, relevant sociodemographic factors, lifestyles, clinical factors and related life course changes, 1-point increment in EHS was associated with increased depression (β = 0.041; 95%CI 0.022, 0.060) and lower mental quality of life (β=-0.037; 95%CI -0.052, -0.021). Conclusions Economic hardship resulting from the great recession in late 2000s was associated with a deterioration of mental health, as reflected by increased depression levels and reduced mental quality of life. Key messages Economic hardship resulting from the recession in late 2000s is associated with a deterioration of mental health. These findings support the notion that economic downturns may have detrimental effects on mental health and support the need for adequate strategies for more vulnerable groups.

Published
2021
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10. Tissue Plasminogen Activator Levels and Risk of Breast Cancer in a Case-Cohort Study on Italian Women: Results from the Moli-sani Study

Author

Costanzo, S, Parisi, R, De Curtis, A, Gamba, S, Russo, L, Persichillo, M, Panzera, T, Marchetti, M, Cerletti, C, De Gaetano, G, Falanga, A, Donati, M, Iacoviello, L, Costanzo S., Parisi R., De Curtis A., Gamba S., Russo L., Persichillo M., Panzera T., Marchetti M., Cerletti C., De Gaetano G., Falanga A., Donati M. B., Iacoviello L., Costanzo, S, Parisi, R, De Curtis, A, Gamba, S, Russo, L, Persichillo, M, Panzera, T, Marchetti, M, Cerletti, C, De Gaetano, G, Falanga, A, Donati, M, Iacoviello, L, Costanzo S., Parisi R., De Curtis A., Gamba S., Russo L., Persichillo M., Panzera T., Marchetti M., Cerletti C., De Gaetano G., Falanga A., Donati M. B., and Iacoviello L.

Abstract

Background Elevated levels of key enzymes of the fibrinolytic system, such as tissue plasminogen activator (tPA), are reported as predictors of poor outcome in cancer patients. Limited information is available about their potential predictive value for breast cancer (BC) risk in the general population. Aim We examined the association of tPA levels with BC risk in a case-cohort study including women from the prospective Moli-sani cohort. Methods A sample of 710 women (mean age: 54.6 ± 12.1 years) was selected as a subcohort and compared with 84 BC cases, in a median follow-up of 4.2 years. Incident cases of BC were validated through medical records. tPA plasma levels were measured using an enzyme-linked immunosorbent assay kit. Hazard ratio (HR) and 95% confidence interval (CI), adjusted for relevant covariates, were estimated by a Cox regression model using the Prentice method. Results Compared with the lowest quartile (<4.9 ng/mL), women in the highest quartile of tPA (>11.2 ng/mL) had increased risk of BC (HR IVvsI: 2.20, 95% CI: 1.13-4.28) after adjusted for age, smoking, education, menopause, and residence. Further adjustment for biochemical markers did not modify this association. The risk of BC increased by 34% for each increase in 1 standard deviation of log-transformed tPA levels (p = 0.046). Elevated levels of tPA were associated mainly with estrogen-receptor-positive BC (2.08, 95% CI: 1.18-3.66). Conclusion Higher levels of tPA, reported to predict cardiovascular risk, are a potential biomarker for BC risk, supporting the hypothesis of a common soil linking the pathogenic mechanisms of hormone-dependent tumors and cardiovascular disease.

Published
2021

13. Association of a traditional Mediterranean diet and non-Mediterranean dietary scores with all-cause and cause-specific mortality: prospective findings from the Moli-sani Study

Author

Bonaccio, M., Di Castelnuovo, A., Costanzo, S., De Curtis, A., Persichillo, M., Cerletti, C., Donati, M. B., de Gaetano, G., Iacoviello, L., Bonanni, A., Decurtis, A., Dicastelnuovo, A., Diprospero, T., Vermylen, J., DePaula Carrasco, I., Giampaoli, S., Spagnuolo, A., Assanelli, D., Centritto, V., Olivieri, M., Gialluisi, A., Gianfagna, F., Ruggiero, E., Magnacca, S., Izzi, B., Marotta, A., Noro, F., Delucia, F., Bracone, F., Dudiez, S., Rago, L., and Panzera, T.

Subjects
0301 basic medicine, Adult, Male, Mediterranean diet, DASH diet, Population, Medicine (miscellaneous), 030209 endocrinology & metabolism, Lower risk, Diet, Mediterranean, 03 medical and health sciences, 0302 clinical medicine, Palaeolithic diet, Risk Factors, Cause of Death, CVD risk factors, Inflammation, Mortality, Nordic diet, Dash, Risk of mortality, Medicine, Humans, Prospective Studies, education, education.field_of_study, 030109 nutrition & dietetics, Nutrition and Dietetics, Proportional hazards model, business.industry, Hazard ratio, Italy, Cardiovascular Diseases, Female, business, Demography
Abstract

To evaluate in an Italian general population, the association with mortality of a traditional Mediterranean diet (MD) and non-Mediterranean dietary (non-MD) patterns, and their combined effect, and to test some biomarkers of cardiovascular (CVD) risk as potential mediators of such associations. Longitudinal analysis on 22,849 men and women aged ≥ 35 years, recruited in the Moli-sani Study (2005–2010), followed up for 8.2 years (median). The MD was assessed by the Mediterranean diet score (MDS). The Dietary Approaches to Stop Hypertension (DASH), the Palaeolithic diet, and the Nordic diet were chosen as reportedly healthy non-MD patterns. Hazard ratios (HR) with 95% confidence intervals (95% CI) were calculated by multivariable Cox regression. Participants reaching higher MDS or DASH diet score experienced lower risk of both all-cause (HR 0.77; 95% CI 0.66–0.90 and 0.81; 0.69–0.96, respectively, highest vs lowest quartile) and CVD (0.77; 0.59–1.00 and 0.81; 0.69–0.96, respectively) death risk; risk reduction associated with the Palaeolithic diet was limited to total and other cause death, whereas the Nordic diet did not alter risk of mortality. Increasing adherence to MD was associated with higher survival in each stratum of non-MD diets. Biomarkers of glucose metabolism accounted for 7% and 21.6% of the association between either MDS or DASH diet, respectively, with total mortality risk. Both the traditional MD and DASH diet may reduce risk of all-cause mortality among Italians, as well as risk of dying from cardiovascular causes. The Palaeolithic diet did not appear to reduce cardiovascular risk, while the Nordic eating pattern was unlikely to be associated with any substantial health advantage.

Published
2020

22. ZBTB12 DNA methylation is associated with coagulation- and inflammation-related blood cell parameters: findings from the Moli-family cohort

Author

Noro, F., Gianfagna, F., Gialluisi, A., De Curtis, A., Di Castelnuovo, A., Napoleone, E., Cerletti, C., Donati, M. B., de Gaetano, G., Hoylaerts, M. F., Iacoviello, L., Izzi, B., Vohnout, B., Arca, M., Lorenzet, R., di Castelnuovo, A., Costanzo, S., di Giuseppe, R., Cutrone, A., Magnacca, S., Crescente, M., Pampuch, A., Tamburrelli, C., Zurlo, F., and Nanni, L.

Subjects
Male, 0301 basic medicine, Myocardial Infarction, Cohort Studies, Pathogenesis, Blood cell, Leukocyte Count, 0302 clinical medicine, PLATELET, Genetics (clinical), Genetics & Heredity, DNA methylation, Granulocyte counts, White blood cell counts, Whole blood coagulation time, Zinc fingers, Cardiovascular risk, Principal Component Analysis, DNA methylation, TRANSCRIPTIONAL REGULATION, Methylation, Middle Aged, Blood Coagulation Factors, DNA-Binding Proteins, MEDITERRANEAN DIET, Haematopoiesis, Granulocyte counts, Zinc fingers, medicine.anatomical_structure, Oncology, CpG site, MONOCYTES, 030220 oncology & carcinogenesis, Female, Life Sciences & Biomedicine, Adult, Biology, Granulocyte, REGION, Young Adult, 03 medical and health sciences, ADHERENCE, White blood cell, Cardiovascular risk, White blood cell counts, Whole blood coagulation time, Genetics, medicine, Humans, Blood Coagulation, Molecular Biology, Science & Technology, Tumor Necrosis Factor-alpha, Research, 030104 developmental biology, TISSUE FACTOR, Immunology, CpG Islands, Granulocytes, Transcription Factors, Developmental Biology
Abstract

Background Zinc finger and BTB domain-containing protein 12 (ZBTB12) is a predicted transcription factor with potential role in hematopoietic development. Recent evidence linked low methylation level of ZBTB12 exon1 to myocardial infarction (MI) risk. However, the role of ZBTB12 in the pathogenesis of MI and cardiovascular disease in general is not yet clarified. We investigated the relation between ZBTB12 methylation and several blood parameters related to cardio-cerebrovascular risk in an Italian family-based cohort. Results ZBTB12 methylation was analyzed on white blood cells from the Moli-family cohort using the Sequenom EpiTYPER MassARRAY (Agena). A total of 13 CpG Sequenom units were analyzed in the small CpG island located in the only translated ZBTB12 exon. Principal component analysis (PCA) was performed to identify groups of CpG units with similar methylation estimates. Linear mixed effect regressions showed a positive association between methylation of ZBTB12 Factor 2 (including CpG units 8, 9–10, 16, 21) and TNF-ɑ stimulated procoagulant activity, a measure of procoagulant and inflammatory potential of blood cells. In addition, we also found a negative association between methylation of ZBTB12 Factor 1 (mainly characterized by CpG units 1, 3–4, 5, 11, and 26) and white blood cell and granulocyte counts. An in silico prediction analysis identified granulopoiesis- and hematopoiesis-specific transcription factors to potentially bind DNA sequences encompassing CpG1, CpG3–4, and CpG11. Conclusions ZBTB12 hypomethylation is linked to shorter TNF-ɑ stimulated whole blood coagulation time and increased WBC and granulocyte counts, further elucidating the possible link between ZBTB12 methylation and cardiovascular disease risk. Electronic supplementary material The online version of this article (10.1186/s13148-019-0665-6) contains supplementary material, which is available to authorized users.

Published
2019

23. Variation of PEAR1 DNA methylation influences platelet and leukocyte function

Author

Izzi, B., Gianfagna, F., Yang, W. -Y., Cludts, K., De Curtis, A., Verhamme, P., Di Castelnuovo, A., Cerletti, C., Donati, M. B., De Gaetano, G., Staessen, J. A., Hoylaerts, M. F., Iacoviello, L., Vohnout, B., Arca, M., Lorenzet, R., Costanzo, S., Di Giuseppe, R., Cutrone, A., Magnacca, S., Crescente, M., Pampuch, A., Tamburrelli, C., Napoleone, E., Zurlo, F., and Nanni, L.

Subjects
Adult, Blood Platelets, Male, 0301 basic medicine, medicine.medical_specialty, Population, Receptors, Cell Surface, DNA methylation, leukocyte function, platelet, PEAR1, 030204 cardiovascular system & hematology, Biology, Epigenesis, Genetic, Cohort Studies, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Leukocytes, Genetics, medicine, Humans, Platelet, Platelet activation, Epigenetics, education, Molecular Biology, Genetics (clinical), epidemiology, public health, epigenetics, platelet aggregation, inflammation, education.field_of_study, Research, Platelet Distribution Width, Methylation, DNA Methylation, Middle Aged, Blood Cell Count, Pedigree, 030104 developmental biology, Endocrinology, Italy, CpG site, Moli-family Investigators, DNA methylation, Female, Developmental Biology
Abstract

BackgroundPlatelet-endothelial aggregation receptor 1 (PEAR-1) is a transmembrane receptor involved in platelet activation and megakaryopoiesis whose expression is driven by DNA methylation.PEAR1variants were associated with differential platelet response to activation and cardiovascular outcomes. We aimed at investigating the link betweenPEAR1methylation and platelet and leukocyte function markers in a family-based population.ResultsWe measuredPEAR1methylation in 605 Moli-family participants with available blood counts, plasma P-selectin and C-reactive protein, whole blood platelet P-selectin, and platelet-leukocyte mixed conjugate measurements. We performed principal component analysis (PCA) to identify groups of highly correlated CpG sites. We used linear mixed regression models (using age, gender, BMI, smoking, alcohol drinking, being a proband for family recruitment, being a member of myocardial infarction (MI) family as fixed effects, and family as a random effect) to evaluate associations betweenPEAR1methylation and phenotypes.PEAR1methylation Factor2, characterized by the previously identified megakaryocyte-specific CpG sites, was inversely associated with platelet-monocyte conjugates, P-selectin, and WBC counts, while positively associated with the platelet distribution width (PDW) and with leukocyte CD11b and L-selectin. Moreover,PEAR1Factor2 methylation was negatively associated with INFLAscore, a low-grade inflammation score. The latter was partially mediated by thePEAR1methylation effect on platelet variables.PEAR1methylation association with WBC measurements and INFLAscore was confirmed in the independent cohort FLEMENGHO.ConclusionsWe report a significant link between epigenetic signatures in a platelet functional gene and inflammation-dependent platelet function variability measured in two independent cohorts.

Published
2019

39. T-wave axis deviation and left ventricular hypertrophy interaction in diabetes and hypertension

Author

Assanelli, Deodato, Castelnuovo, A. D., Rago, L., Badilini, F., Vinetti, G., Gianfagna, F., Salvetti, Massimo, Zito, F., Donati, M. B., Gaetano, G. d., Iacoviello, L., and o. b., Of

Subjects
Diabetese, Male, medicine.medical_specialty, Epidemiology, Population, heart failure, Comorbidity, Electrocardiography, Public Health, Hypertension, Cardiovascular Diseases, Left ventricular hypertrophy, Sensitivity and Specificity, Coronary artery disease, Risk Factors, Internal medicine, Diabetes mellitus, Diabetes Mellitus, Prevalence, medicine, Humans, cardiovascular diseases, Myocardial infarction, Sex Distribution, education, education.field_of_study, diabetes, medicine.diagnostic_test, business.industry, Reproducibility of Results, medicine.disease, Causality, Estimated cardiovascular risk, Italy, Heart failure, Cardiology, Left axis deviation, Female, Hypertrophy, Left Ventricular, Cardiology and Cardiovascular Medicine, business
Abstract

Electrocardiographic signs of left ventricular hypertrophy (ECG-LVH) and T-wave axis (TA) deviation are independent predictors of fatal and non fatal events. We assessed the prevalence of ECG-LVH, TA abnormalities and their combination according to the presence or absence of diabetes and/or hypertension in a large sample of the adult general Italian population. Data from 10,184 women (54 ± 11 years) and 8775 men (54 ± 11 years) were analyzed from the Moli-sani cohort, a database of randomly recruited adults (age >35) from the general population of Molise, a central region of Italy that includes collection of standard 12-lead resting ECG. Subjects with previous myocardial infarction, angina, cerebrovascular disease or left bundle brunch block or missing values for TA or ECG-LVH have been excluded. TA was measured from the standard 12-lead ECG and it was defined as the rotation of the T wave in the frontal plane as computed by a proprietary algorithm (CalECG/Bravo, AMPS-LLC, NY). ECG-LVH was defined as Sokolow Lyon voltage (SLv) >35 mm or Cornell voltage duration Product (CP) >= 2440 mm*ms. Among subjects with ECG-LVH, prevalence of hypertension was 59.0% and 49.7%, respectively for men and women, whereas that of diabetes was 10.7% and 5.7%. In hypertensives, TA was normal in 72.3% of subjects, borderline in 24.8% and abnormal in 2.9%. In diabetics, TA was normal in 70.4% of subjects, borderline in 26.5% and abnormal in 3.1%. In both hypertensive and diabetic subjects, the prevalence of ECG-LVH, was significantly greater in subjects with borderline or abnormal TA. Hypertension was an independent predictor of abnormal TA (odd ratio: 1.38, P = .025). These results suggest that hypertension might play a relevant role in the pathogenesis of TA deviation.

Published
2013
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47. A score of low-grade inflammation and risk of mortality: prospective findings from the Moli-sani study

Author

Bonaccio, M., Di Castelnuovo, A., Pounis, G., De Curtis, A., Costanzo, S., Persichillo, M., Cerletti, C., Donati, M. B., De Gaetano, G., Iacoviello, L., Vermylen, J., Carrasco, I. P., Giampaoli, S., Spagnuolo, A., Assanelli, D., Centritto, V., Spagnuolo, P., Staniscia, D., Zito, F., Bonanni, A., Lorenzet, R., Mascioli, A., Olivieri, M., Rotilio, D., Gianfagna, F., Giacci, M., Padulo, A., Petraroia, D., Marracino, F., Spinelli, M., Silvestri, C., De Lucia, F., Vohnout, B., Coordinator, G., Verna, A., Di Lillo, M., Di Stefano, I., Pannichella, A., Vizzarri, A. R., Pampuch, A., Arcari, A., Barbato, D., Bracone, F., Di Giorgio, C., Magnacca, S., Panebianco, S., Chiovitti, A., Caccamo, S., Caruso, V., Rago, L., Cugino, D., Ferri, A., Castaldi, C., Mignogna, M., Guszcz, T., Di Giuseppe, R., Barisciano, P., Buonaccorsi, L., Centritto, F., Cutrone, A., Fanelli, F., Santimone, I., Sciarretta, A., Sorella, I., Plescia, E., Molinaro, A., Cavone, C., Galuppo, G., D'Angelo, D., Ramacciato, R., and Molise, A. S. R. D.

Subjects
Adult, Male, Risk, 0301 basic medicine, medicine.medical_specialty, Population, 030204 cardiovascular system & hematology, Article, 03 medical and health sciences, 0302 clinical medicine, Cause of Death, Internal medicine, Epidemiology, medicine, Risk of mortality, Humans, Prospective Studies, Risk factor, education, Prospective cohort study, Aged, Cause of death, Aged, 80 and over, Inflammation, education.field_of_study, business.industry, Hazard ratio, Hematology, Middle Aged, Surgery, 030104 developmental biology, Quartile, Female, business, Biomarkers, Follow-Up Studies
Abstract

Low-grade inflammation is associated with an increased risk of chronic degenerative disease, but its relationship with mortality is less well explored. We aimed at evaluating, at a large epidemiological level, the possible association of low-grade inflammation, as measured by a composite score, with overall mortality risk. We conducted a population-based prospective investigation on 20,337 adult subjects free from major hematological disease and acute inflammatory status, randomly recruited from the general population of the Moli-sani study. A low-grade inflammation score was obtained from the sum of 10-tiles of plasmatic (C-reactive protein) and cellular (leukocyte and platelet counts, granulocyte/lymphocyte ratio) biomarkers of low-grade inflammation; higher levels indicated increased low-grade inflammation. Hazard ratios were calculated using multivariable Cox proportional hazard models with 95% confidence intervals. At the end of follow-up (median 7.6 years), 837 all-cause deaths were recorded. As compared to subjects in the lowest quartile of the low-grade inflammation score, those in the highest category had a significantly increased risk in overall mortality (HR=1.44; 1.17-1.77), independently of possible confounders, including the presence of chronic diseases and a number of health-related behaviors. The magnitude of the association of low-grade inflammation with mortality was relatively higher in type 2 diabetic patients (HR=2.90; 1.74-4.84) and in individuals with a history of cardiovascular disease (HR=2.48; 1.50-4.11) as compared to their counterparts who were free from the disease. In conclusion, an elevated degree of low-grade inflammation, as measured by a composite score of inflammatory biomarkers, is an independent risk factor for total mortality in an apparently healthy adult general population.

Published
2016

50. Impact of combined healthy lifestyle factors on survival in an adult general population and in high-risk groups: prospective results from the Moli-sani Study.

Author

Bonaccio, M., Di Castelnuovo, A., Costanzo, S., De Curtis, A., Persichillo, M., Cerletti, C., Donati, M. B., Gaetano, G., Iacoviello, L., de Gaetano, G, and Moli-sani Study Investigators

Subjects
MEDITERRANEAN diet, BLOOD lipids, C-reactive protein, COMPETING risks
Abstract

Background: There is poor knowledge on the association between combined lifestyles with mortality risk among individuals at high risk, and little is known on the biological mechanisms that could be on the pathway.Methods: Longitudinal analysis on 22 839 individuals from the Moli-sani Study (Italy, 2005-2010). Among them, we identified 5200 elderly individuals (≥65 year), 2127 subjects with diabetes and 1180 with cardiovascular disease (CVD) at baseline. A healthy lifestyle score (HLS) was calculated, allocating 1 point for each of the following: abstention from smoking; adherence to Mediterranean diet; physical activity; absence of abdominal obesity. Hazard ratios (HR) with 95% confidence intervals (95%CI) were calculated by multivariable Cox regression and competing risk models.Results: During 8.2 years of follow-up, 1237 deaths occurred. In the general population, adherence to all four healthy lifestyles, compared with none or 1, was associated with lower risk of all-cause (HR = 0.53; 95%CI:0.39-0.72), CVD (HR = 0.54; 0.32-0.91), cancer (HR = 0.62; 0.39-1.00) and mortality from other causes (HR = 0.39; 0.19-0.81). A 1-point increase in HLS was associated with 20%, 22% and 24% lower risk of total mortality among the elderly, in subjects with diabetes or CVD, respectively. Traditional (e.g. blood lipids), inflammatory (e.g. C-reactive protein) and novel biomarkers (e.g. markers of cardiac damage) accounted for up to 24% of the association of HLS with all-cause mortality risk in the general population.Conclusions: The impact of combined four healthy lifestyles on survival was considerable, both in the general population and among high-risk subgroups. Inflammatory and novel biomarkers of CVD risk explained a substantial proportion of this association. [ABSTRACT FROM AUTHOR]

Published
2019
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