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Recruiting NCT04050956

French Cohort of Myocardial Infarction Evaluation

— Observational Acute Myocardial Infarction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Acute Myocardial Infarction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

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.

Primary outcome measures

  • In-hospital mortality [Time frame: Through the end of initial hospitalization, an average of 5 days]
  • In-hospital outcomes [Time frame: Through the end of initial hospitalization, an average of 5 days]
  • Lipopretein 1 evolution [Time frame: 9 months after the end of initial hospitalization]
Secondary outcome measures (9)
  • Cardiovascular outcomes during follow-up [Time frame: Up to 20 years]
  • Non cardiovascular outcomes during follow-up [Time frame: Up to 20 years]
  • Relationship between patients profile and mortality and cardiovascular morbidity outcomes according to management [Time frame: Up to 20 years]
  • Relationship between patients profile and mortality and non-cardiovascular morbidity outcomes according to management [Time frame: Up to 20 years]
  • Oral comorbidities [Time frame: Up to 20 years]
  • Sleep disordered breathing comorbidities [Time frame: Up to 20 years]
  • Evaluate the path of care combined with patient care practices following an acute myocardial infarction [Time frame: 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 [Time frame: Up to 20 years]
  • Cost-utility: incremental (or decremental) cost-utility ratio during follow-up [Time frame: Up to 20 years]

Eligibility criteria

Inclusion criteria

  • 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")

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Hôpital Bichat, AP-HP — Paris

Publications

  • Hasdai D, Behar S, Wallentin L, Danchin N, Gitt AK, Boersma E, Fioretti PM, Simoons ML, Battler A. A prospective survey of the characteristics, treatments and outcomes of patients with acute coronary syndromes in Europe and the Mediterranean basin; the Euro Heart Survey of Acute Coronary Syndromes (Euro Heart Survey ACS). Eur Heart J. 2002 Aug;23(15):1190-201. doi: 10.1053/euhj.2002.3193. PMID 12127921
  • 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

Identifiers

NCT: NCT04050956 · NI17011

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗