French Registry of Acute ST-elevation or Non-ST-elevation Myocardial Infarction 2015

Myocardial Infarction Clinical Trial

— FASTMI2015  

Official title:

French Registry of Acute ST-elevation or Non-ST-elevation Myocardial Infarction 2015

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02566200
• Other study ID #: 15597
• Status: Active, not recruiting
• Start date: October 2015
• Est. completion date: October 2027

Study information

• Verified date: September 2022
• Source: French Cardiology Society
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Over the last two decades, considerable progress has been made in the management of myocardial infarction, both in the acute phase and in monitoring beyond the hospital phase. However changing practices in the "real world" and their impact on prognosis in the medium and long term patients admitted to the intensive care unit for acute myocardial infarction are relatively little studied exhaustively.

The study of clinical, biological and genetic characteristics of patients and their conditions of care, help to identify patients at risk for increased morbidity and mortality after myocardial infarction and could be the basis for the subsequent realization of specific studies on the optimal therapeutic management of the disease according to the different risk profiles.

Description:

This is a multicenter observational study, given to 300 prospective medical facilities, including a clinic or intensive care unit entitled to receive emergency acute coronary syndromes.

Patients will be recruited consecutively during a period of 2 months.

Annual follow-ups will be conducted during 10 years of clinical research technicians of the French Society of Cardiology, mail and / or telephone contact with the municipalities of birth, treating physicians and patients.

The ambition of the 2015 Observatory of the French Society of Cardiology is through a photograph "scale" of the practices in France at present, to ensure consistency in the quality of care for hospitalized patients heart attack; the investigation will emphasize the strengths but also the weaknesses of our health care system so that should improve. Finally, the observation of a large population of the real world will give the opportunity to assess the interactions between the different types of treatments used and check their possible synergy or incompatibilities.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5000
• Est. completion date: October 2027
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female aged over 18 years

2. Patients admitted within 48 hours of onset of symptoms in a coronary intensive care unit (USIC) for acute myocardial infarction (MI) defined by:

A rise and fall of typical troponin (or CPKMb) associated with at least one of the following:

• symptoms consistent with myocardial ischemia

• development of pathological Q waves

• repolarisation disorders related to ischemia (or in addition to ST depression, T wave inversion)

3. And having agreed to participate in the study.

Exclusion Criteria:

1. Refusal to consent

2. MI occurring in the 48 hours after therapeutic intervention (bypass surgery or coronary angioplasty or other surgical procedure)

3. Diagnosis of myocardial reversed in favor of an alternative diagnosis

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Non-ST Elevated Myocardial Infarction

Locations

Country	Name	City	State
France	HEGP	Paris

Sponsors (2)

Lead Sponsor	Collaborator
French Cardiology Society	Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (7)

Belle L, Cayla G, Cottin Y, Coste P, Khalife K, Labèque JN, Farah B, Perret T, Goldstein P, Gueugniaud PY, Braun F, Gauthier J, Gilard M, Le Heuzey JY, Naccache N, Drouet E, Bataille V, Ferrières J, Puymirat E, Schiele F, Simon T, Danchin N; FAST-MI 2015 — View Citation

Puymirat E, Bonaca M, Fumery M, Tea V, Aissaoui N, Lemesles G, Bonello L, Ducrocq G, Cayla G, Ferrières J, Schiele F, Simon T, Danchin N; FAST-MI investigators. Atherothrombotic risk stratification after acute myocardial infarction: The Thrombolysis in My — View Citation

Puymirat E, Bonaca M, Iliou MC, Tea V, Ducrocq G, Douard H, Labrunee M, Plastaras P, Chevallereau P, Taldir G, Bataille V, Ferrières J, Schiele F, Simon T, Danchin N; FAST-MI investigators. Outcome associated with prescription of cardiac rehabilitation ac — View Citation

Puymirat E, Cayla G, Cottin Y, Elbaz M, Henry P, Gerbaud E, Lemesle G, Popovic B, Labèque JN, Roubille F, Andrieu S, Farah B, Schiele F, Ferrières J, Simon T, Danchin N. Twenty-year trends in profile, management and outcomes of patients with ST-segment el — View Citation

Puymirat E, Simon T, Cayla G, Cottin Y, Elbaz M, Coste P, Lemesle G, Motreff P, Popovic B, Khalife K, Labèque JN, Perret T, Le Ray C, Orion L, Jouve B, Blanchard D, Peycher P, Silvain J, Steg PG, Goldstein P, Guéret P, Belle L, Aissaoui N, Ferrières J, Sc — View Citation

Puymirat E, Simon T, Danchin N; FAST-MI Investigators. Response by Puymirat et al to Letter Regarding Article, "Acute Myocardial Infarction Changes in Patient Characteristics, Management, and 6-Month Outcomes Over a Period of 20 Years in the FAST-MI Progr — View Citation

Schiele F, Puymirat E, Ferrières J, Simon T, Fox KAA, Eikelboom J, Danchin N; FAST-MI investigators. The FAST-MI 2005-2010-2015 registries in the light of the COMPASS trial: The COMPASS criteria applied to a post-MI population. Int J Cardiol. 2019 Mar 1;2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality 1 year after hospitalization for a myocardial infarction		1 year after hospitalization
Secondary	All cause mortality 10 years after hospitalization for a myocardial infarction		10 years after hospitalization
Secondary	To determine the impact of genetic, serology, fecal biomarkers on the myocardial infarction and its complications.		10 years after hospitalization