French Cohort of Myocardial Infarction Evaluation

Обзор

Over the last two decades, considerable progress has been made in the management of Acute Myocardial Infarction (AMI), both in the acute phase and in monitoring beyond the hospital phase. Nevertheless, the evolution of care practices and their impact on the mid- and long-term prognosis of patients admitted to the intensive care unit for acute myocardial infarction remain relatively little studied exhaustively. The aim of this study is to assess the profile of AMI patients, their management and follow-up in order to evaluate the relationship between these factors and outcomes.

Подробное описание

The FRENCHIE registry is a French multicenter prospective observational study. All the eligible consecutive patients admitted within 48 hours after symptom onset in a cardiac ICU for an acute myocardial infarction.

This hospital registry will be linked to the national databases, in order to collect follow-up clinical outcomes and health care consumption.

Первичные конечные точки

• In-hospital mortality [Срок оценки: Through the end of initial hospitalization, an average of 5 days]
• In-hospital outcomes [Срок оценки: Through the end of initial hospitalization, an average of 5 days]
• Lipopretein 1 evolution [Срок оценки: 9 months after the end of initial hospitalization]

Вторичные конечные точки (9)

• Cardiovascular outcomes during follow-up [Срок оценки: Up to 20 years]
• Non cardiovascular outcomes during follow-up [Срок оценки: Up to 20 years]
• Relationship between patients profile and mortality and cardiovascular morbidity outcomes according to management [Срок оценки: Up to 20 years]
• Relationship between patients profile and mortality and non-cardiovascular morbidity outcomes according to management [Срок оценки: Up to 20 years]
• Oral comorbidities [Срок оценки: Up to 20 years]
• Sleep disordered breathing comorbidities [Срок оценки: Up to 20 years]
• Evaluate the path of care combined with patient care practices following an acute myocardial infarction [Срок оценки: Up to 20 years]
• Evaluate the relevance of European Society of Cardiology (ESC), American Heart Association/American College of Cardiology (AHA / ACC) guidelines regarding management of AMI patients [Срок оценки: Up to 20 years]
• Cost-utility: incremental (or decremental) cost-utility ratio during follow-up [Срок оценки: Up to 20 years]

Критерии участия

Критерии включения

• Myocardial infarction (MI) within 48h of symptom onset, characterized by the typical increased or fall of troponin (or CPKMB) associated with at least one of the following elements :
• Symptoms compatible with myocardial ischemia
• Appearance of pathological Q waves
• ST- T changes compatible with myocardial ischemia (ST segment elevation or depression, T-wave inversion)
• Written consent.
• Covered by French medical insurance ("Sécurité Sociale")

Критерии исключения

• Iatrogenic MI defined as MI occurring within 48h of a therapeutic procedure
• AMI diagnosis invalidated in favor of another diagnosis

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• Hôpital Bichat, AP-HP — Paris

Публикации

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• Pedersen TR, Kjekshus J, Berg K, Haghfelt T, Faergeman O, Faergeman G, Pyorala K, Miettinen T, Wilhelmsen L, Olsson AG, Wedel H; Scandinavian Simvastatin Survival Study Group. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). 1994. Atheroscler Suppl. 2004 Oct;5(3):81-7. doi: 10.1016/j.atherosclerosissup.2004.08. PMID 15531279
• Sacks FM, Pfeffer MA, Moye LA, Rouleau JL, Rutherford JD, Cole TG, Brown L, Warnica JW, Arnold JM, Wun CC, Davis BR, Braunwald E. The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels. Cholesterol and Recurrent Events Trial investigators. N Engl J Med. 1996 Oct 3;335(14):1001-9. doi: 10.1056/NEJM199610033351401. PMID 8801446
• Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial. Lancet. 2002 Jul 6;360(9326):7-22. doi: 10.1016/S0140-6736(02)09327-3. PMID 12114036
• GUSTO investigators. An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction. N Engl J Med. 1993 Sep 2;329(10):673-82. doi: 10.1056/NEJM199309023291001. PMID 8204123
• Andersen HR, Nielsen TT, Rasmussen K, Thuesen L, Kelbaek H, Thayssen P, Abildgaard U, Pedersen F, Madsen JK, Grande P, Villadsen AB, Krusell LR, Haghfelt T, Lomholt P, Husted SE, Vigholt E, Kjaergard HK, Mortensen LS; DANAMI-2 Investigators. A comparison of coronary angioplasty with fibrinolytic therapy in acute myocardial infarction. N Engl J Med. 2003 Aug 21;349(8):733-42. doi: 10.1056/NEJMoa025 PMID 12930925
• Keeley EC, Boura JA, Grines CL. Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials. Lancet. 2003 Jan 4;361(9351):13-20. doi: 10.1016/S0140-6736(03)12113-7. PMID 12517460
• Danchin N, Vaur L, Genes N, Etienne S, Angioi M, Ferrieres J, Cambou JP. Treatment of acute myocardial infarction by primary coronary angioplasty or intravenous thrombolysis in the "real world": one-year results from a nationwide French survey. Circulation. 1999 May 25;99(20):2639-44. doi: 10.1161/01.cir.99.20.2639. PMID 10338456

Идентификаторы

NCT: NCT04050956 · NI17011

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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