French Cohort of Myocardial Infarction Evaluation

NCT04050956 | Recruiting

• 1 other identifier: NI17011
• Study Type: observational
• Target: 30,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Myocardial Infarction

Keywords

Acute Myocardial Infarction; Registry; Outcomes; Medico-economic evaluation; Comorbidities

Outcome Measures

Primary Outcomes (3)

• In-hospital mortality

  In-hospital mortality

  Through the end of initial hospitalization, an average of 5 days

• In-hospital outcomes

  To measure the in-hospital major cardiovascular events : recurrence of AMI, myocardial revascularization, stroke

  Through the end of initial hospitalization, an average of 5 days

• Lipopretein 1 evolution

  To evaluate plasma concentrations of Lpa and its dynamic pattern during hospital index and 3-9 months following hospitalization.

  9 months after the end of initial hospitalization

Secondary Outcomes (9)

• Cardiovascular outcomes during follow-up

  Up to 20 years

• Non cardiovascular outcomes during follow-up

  Up to 20 years

• Relationship between patients profile and mortality and cardiovascular morbidity outcomes according to management

  Up to 20 years

• Relationship between patients profile and mortality and non-cardiovascular morbidity outcomes according to management

  Up to 20 years

• Oral comorbidities

  Up to 20 years

Study Arms (1)

Myocardial infarction

As it is an observational study, no intervention is planned. However, nested clinical interventional trials are planned for which a specific registration will be done

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive eligible (cf eligibility criteria) patients admitted in one of the Intensive Coronary Units participating to the study.

You may qualify if:

• 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")

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Novartis: collaborator

Study Sites (1)

Hôpital Bichat, AP-HP

Paris, 75018, France

RECRUITING

Related Publications (31)

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  PMID: 17893635 BACKGROUND

• Hanssen M, Cottin Y, Khalife K, Hammer L, Goldstein P, Puymirat E, Mulak G, Drouet E, Pace B, Schultz E, Bataille V, Ferrieres J, Simon T, Danchin N; FAST-MI 2010 Investigators. French Registry on Acute ST-elevation and non ST-elevation Myocardial Infarction 2010. FAST-MI 2010. Heart. 2012 May;98(9):699-705. doi: 10.1136/heartjnl-2012-301700.

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• Danchin N, Coste P, Ferrieres J, Steg PG, Cottin Y, Blanchard D, Belle L, Ritz B, Kirkorian G, Angioi M, Sans P, Charbonnier B, Eltchaninoff H, Gueret P, Khalife K, Asseman P, Puel J, Goldstein P, Cambou JP, Simon T; FAST-MI Investigators. Comparison of thrombolysis followed by broad use of percutaneous coronary intervention with primary percutaneous coronary intervention for ST-segment-elevation acute myocardial infarction: data from the french registry on acute ST-elevation myocardial infarction (FAST-MI). Circulation. 2008 Jul 15;118(3):268-76. doi: 10.1161/CIRCULATIONAHA.107.762765. Epub 2008 Jun 30.

  PMID: 18591434 BACKGROUND

• Danchin N, Puymirat E, Steg PG, Goldstein P, Schiele F, Belle L, Cottin Y, Fajadet J, Khalife K, Coste P, Ferrieres J, Simon T; FAST-MI 2005 Investigators. Five-year survival in patients with ST-segment-elevation myocardial infarction according to modalities of reperfusion therapy: the French Registry on Acute ST-Elevation and Non-ST-Elevation Myocardial Infarction (FAST-MI) 2005 Cohort. Circulation. 2014 Apr 22;129(16):1629-36. doi: 10.1161/CIRCULATIONAHA.113.005874. Epub 2014 Mar 21.

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• Ferrieres J, Bataille V, Leclercq F, Geslin P, Ruidavets JB, Grollier G, Bernard P, Cambou JP, Simon T, Danchin N. Patterns of statin prescription in acute myocardial infarction: the French registry of Acute ST-elevation or non-ST-elevation Myocardial Infarction (FAST-MI). Atherosclerosis. 2009 Jun;204(2):491-6. doi: 10.1016/j.atherosclerosis.2008.09.031. Epub 2008 Oct 8.

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• Simon T, Verstuyft C, Mary-Krause M, Quteineh L, Drouet E, Meneveau N, Steg PG, Ferrieres J, Danchin N, Becquemont L; French Registry of Acute ST-Elevation and Non-ST-Elevation Myocardial Infarction (FAST-MI) Investigators. Genetic determinants of response to clopidogrel and cardiovascular events. N Engl J Med. 2009 Jan 22;360(4):363-75. doi: 10.1056/NEJMoa0808227. Epub 2008 Dec 22.

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• Puymirat E, Simon T, Steg PG, Schiele F, Gueret P, Blanchard D, Khalife K, Goldstein P, Cattan S, Vaur L, Cambou JP, Ferrieres J, Danchin N; USIK USIC 2000 Investigators; FAST MI Investigators. Association of changes in clinical characteristics and management with improvement in survival among patients with ST-elevation myocardial infarction. JAMA. 2012 Sep 12;308(10):998-1006. doi: 10.1001/2012.jama.11348.

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• Puymirat E, Schiele F, Steg PG, Blanchard D, Isorni MA, Silvain J, Goldstein P, Gueret P, Mulak G, Berard L, Bataille V, Cattan S, Ferrieres J, Simon T, Danchin N; FAST-MI investigators. Determinants of improved one-year survival in non-ST-segment elevation myocardial infarction patients: insights from the French FAST-MI program over 15 years. Int J Cardiol. 2014 Nov 15;177(1):281-6. doi: 10.1016/j.ijcard.2014.09.023. Epub 2014 Sep 28.

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• Mesnier J, Cottin Y, Coste P, Ferrari E, Schiele F, Lemesle G, Thuaire C, Angoulvant D, Cayla G, Bouleti C, Gallet de Saint Aurin R, Goube P, Lhermusier T, Dillinger JG, Paganelli F, Saib A, Prunier F, Vanzetto G, Dubreuil O, Puymirat E, Boccara F, Eltchaninoff H, Cachanado M, Rousseau A, Drouet E, Steg PG, Simon T, Danchin N. Hospital admissions for acute myocardial infarction before and after lockdown according to regional prevalence of COVID-19 and patient profile in France: a registry study. Lancet Public Health. 2020 Oct;5(10):e536-e542. doi: 10.1016/S2468-2667(20)30188-2. Epub 2020 Sep 18.

  PMID: 32950075 RESULT

• Gautier A, Danchin N, Ducrocq G, Rousseau A, Cottin Y, Cayla G, Prunier F, Durand-Zaleski I, Ravaud P, Angoulvant D, Coste P, Lemesle G, Bouleti C, Popovic B, Ferrari E, Silvain J, Dubreuil O, Lhermusier T, Goube P, Schiele F, Vanzetto G, Aboyans V, Gallet R, Eltchaninoff H, Thuaire C, Dillinger JG, Paganelli F, Gourmelen J, Steg PG, Simon T; FRENCHIE investigators. Rationale and design of the FRENch CoHort of myocardial Infarction Evaluation (FRENCHIE) study. Arch Cardiovasc Dis. 2024 Jun-Jul;117(6-7):417-426. doi: 10.1016/j.acvd.2024.04.004. Epub 2024 May 22.

  PMID: 38821761 DERIVED

Study Officials

• Philippe Gabriel STEG

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tabassome SIMON

CONTACT

01 40 01 13 93; tabassome.simon@aphp.fr

Philippe Gabriel STEG

CONTACT

01 40 25 80 80; gabriel.steg@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 9, 2019
• Study Start: March 11, 2019
• Primary Completion (Estimated): March 22, 2029
• Study Completion (Estimated): March 22, 2049
• Last Updated: June 25, 2025

Record last verified: 2025-06

Locations

FR (1)