The patients'actual level of CV risk is lower than expected. However, this is not surprising: beside the fact that the cohort is younger than expected, current patients are more widely exposed to preventive measures. In fact, the rate of events reported in previous or observational studies reflects clinical practice at that time and overestimates the current risk. The decision to modify the study endpoint fits well with the public health-oriented design of this GP based project and shows that a trial is simply one part of a strategy of comprehensive prospective monitoring and assessment of all those patients deemed to be at a specific risk.
Their epidemiological outcomes over the medium-long term provide the most important knowledge from which to interpret the experimental results, which will show whether or not the "new" treatment adds a specific advantage to the "natural" history of this population i.
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Similarly, the benefit of n-3 PUFA in Japanese people suggests that it might be replicated in other populations, and might be even more substantial with higher levels of intake [ 40 ]. Novel results like this in the field of cardiology fuel the hypothesis of anti-arrhythmic and anti-atherosclerotic effects of n-3 PUFA and show how important it is to testing their efficacy in a GP's population of patients at high CV risk.
This protocol is the result of a collaborative effort which involved the entire research network of GPs with the collaboration of the investigators who are dedicated to the study conduction and management see appendix. SB is responsible for statistical and data analysis. All authors will participate in the interpretation of results. The final version of the paper has been revised and approved by the members of the Steering Committee and of the Scientific and Organizing Secretariat. We thank the women and men who agreed to participate in the study. The Collaborative Group includes the scientific research society in general practice centre for study and research in general practice -CSeRMEG ; association of general practitioners Italian federation of general practitioners -FIMMG; health consorzio -CoS; interdisciplinary medical culture association -Ass.
SPA provided the experimental treatment. We thank J. Baggott for kindly editing the manuscript. Writing Committee for this paper : F. Avanzini, S. Barlera, V. Caimi, P. Longoni, R. Marchioli, MC. Roncaglioni, MG.
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Silletta, G. Tognoni, M. Steering Committee : M. Tombesi chairman , G. Tognoni co-chairman , E. Massa, W. Marrocco, M. Micalella, V. Longoni, L. Aprile, F. Avanzini, MG. Data Safety Monitoring Board : E. Geraci chairman , N. Giansiracusa, L. Rocchetti, A. Decarli, R. Events Validation Committee : C. Alli, E. Beghi, V. Bertele' A. Roncaglioni coordinator , L. Monesi, I. Marzona, M. Baviera, S. Milani, E. Nicolis, C. Casola, F.
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Pioggiarella, M. Scarano, RM. Marfisi A. Flamminio, L. Mancino, B.
Abstract Background The optimization of preventive strategies in patients at high risk of cardiovascular events and the evaluation of bottlenecks and limitations of transferring current guidelines to the real world of clinical practice are important limiting steps to cardiovascular prevention. Trial registration ClinicalTrials. Background Cardiovascular diseases CVD are the leading cause of death in middle-aged and older adults in most European countries. Inadequate control of modifiable risk factors has been documented in various surveys [ 6 - 12 ] so there is considerable potential for improving cardiovascular prevention, especially in everyday clinical practice While it is easy to see that general practice is a suitable setting for large-scale randomized controlled trials RCTs and prospective outcome-oriented studies [ 13 - 15 ], it is still rare to find general practice-based reports in the formulation and enforcement of guidelines for primary care physicians [ 16 ].
Open in a separate window. Figure 1. Study procedures GPs were selected either through participation in previous research projects [ 16 , 35 ] or through the investigators' registries at local health units. Updated information on any new diagnosis of CVD, control of risk factors, changes in lifestyle or dietary habits, and use of medications is also collected All patients are to be followed up to the scheduled end of study, regardless of adherence to or discontinuation of the treatment for any reason.
Efficacy The main endpoint of the trial testing the efficacy of n-3 PUFA treatments is cardiovascular death or hospitalization for cardiovascular reasons. Safety All serious adverse events defined as fatal, life-threatening, requiring or prolonging hospitalization, permanently disabling or incapacitating, which may jeopardize the subject or which may require medical or surgical intervention , not necessarily drug-related, are reported on a standard form and communicated to the study Coordinating Center within 24 hour of notification of their occurrence.
Statistical aspects The primary endpoint at the start of the study was the cumulative rate of death plus non-fatal-MI and non-fatal stroke. Figure 2. Authors' contributions This protocol is the result of a collaborative effort which involved the entire research network of GPs with the collaboration of the investigators who are dedicated to the study conduction and management see appendix.
Acknowledgements We thank the women and men who agreed to participate in the study. Satolli Events Validation Committee : C. Scientific and Organising Secretariat : M. The burden of cardiovascular diseases mortality in Europe.
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Eur Heart J. Monitoring trends and determinants in cardiovascular disease. Global and regional burden of disease and risk factors, systematic analysis of population health data. Economic burden of cardiovascular disease in the enlarged European Union. European guidelines on cardiovascular disease prevention in clinical practice. Secondary prevention in coronary heart disease: baseline survey of provision in general practice.
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BMJ Clinical research ed. Ineffective secondary prevention in survivors of cardiovascular events in the US population: report from the Third National Health and Nutrition Examination Survey. Arch Inter Med. Acceptance of guideline recommendations and perceived implementation of coronary heart disease prevention among primary care physicians in five European countries: the Reassessing European Attitudes about Cardiovascular Treatment REACT survey. Family Practice. Is global cardiovascular risk considered in current practice?
Treatment and control of hypertension, hyperlipidemia, and diabetes according to patients' risk level. Vascular Health and Risk Management. Appropriate use of antiplatelets: is prescription in daily practice influenced by the global cardiovascular risk? Eur J Clin Pharmacol. International prevalence, recognition, and treatment of cardiovascular risk factors in outpatients with atherothrombosis. The research needs of primary care. Trials must be relevant to patients. The need for research in primary care.
Dietary supplementation with n-3 polyunsaturated fatty acids and vitamin E after myocardial infarction: results of the GISSI-Prevenzione trial.
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Early protection against sudden death by n-3 polyunsaturated fatty acids after myocardial infarction: time-course analysis of the results of the Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico GISSI -Prevenzione. How general practitioners perceive and grade the cardiovascular risk of their patients. Eur J Cardiovasc Prev Rehabil. The inverse relation between fish consumption and year mortality from coronary heart disease.
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New Engl J Med. He has published a number of articles, reviews and anthologies on Hispanic literature in general. The text includes a dialogue with Domenico Mogavero and a preface by Dionigi Tettamanzi. He is also writes the "Oltre Tevere" blog www. Twitter: oltreteveregg.
He has been writing about religious issues and events since and has travelled abroad more than a hundred times, following John Paul II and Benedict XVI. He has written more than 15 books on history and religion. He studied journalism in Mexico and has worked for various publications and television and radio stations in many Hispanic countries. Gianni Gennari , is a Roman theologian and a journalist.
He studied literature, philosophy and theology in Rome, Paris and Freiburg in Breisgau, he hastaught ancient literature and history of philosophy in secondary schools and moral theology and philosophy of religion in many different universities. He began his journalistic career in , becoming a Vaticanologist for Italian national broadcasting company RAI. He contributes to many newspapers and scientific publications and has written many books with various publishers Ancora, Piemme, San Paolo, Lev, Rcs. Luca Rolandi was born in Turin in , where he came to live after completing his studies in Genoa.
A journalist and scholar, with a PhD in social and religious history, he is also the author of a number of essays on Catholic figures and events in Italy. He was involved in institutional press offices and cultural communication and coordination of large online events, including the most significant experiences of the Torino Winter Olympic Games. Guido Horst was born in Cologne in He graduated in history and political science in Cologne and Bonn.
He lives in Blankenheim near Cologne and in Rome. He is married and has two children. Antoine-Marie Izoard is a French Vatican correspondent. He has lived in Rome since and is the director of I. Once the public relations director of the French diocese of Bordeaux, he was also a journalist at Vatican Radio for six years. Today he contributes to major international news agencies, radio stations, weeklies and French television broadcasters.
Marek Lehnert was born in in Poland and graduated in literature from the University of Warsaw. He is currently a correspondent for the public radio broadcaster Polskie Radio. Fabrizio Mastrofini Rome, , is a religion journalist living and working in Rome. He has published a number of books on the Church in Italy and across the world.
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