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

Active, not recruiting

• Conditions: Myocardial Infarction

• Registration Number: NCT02566200
• Lead Sponsor: French Cardiology Society

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-09-30
• Study First Submitted QC: 2015-09-30
• Study Start: 2015-10
• Study First Posted: 2015-10-02
• Primary Completion: 2017-05
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-07
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 5000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All cause mortality 1 year after hospitalization for a myocardial infarction	1 year after hospitalization

Secondary Outcome Measures

Name	Time	Method
To determine the impact of genetic, serology, fecal biomarkers on the myocardial infarction and its complications.	10 years after hospitalization
All cause mortality 10 years after hospitalization for a myocardial infarction	10 years after hospitalization

Trial Locations

Locations (1)

HEGP; 🇫🇷 Paris, France