French Cohort of Myocardial Infarction Evaluation

Recruiting

• Conditions: Acute Myocardial Infarction

• Registration Number: NCT04050956
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

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.

Study Timeline

• Study Start: 2019-03-11
• Study First Submitted: 2019-08-02
• Study First Submitted QC: 2019-08-06
• Study First Posted: 2019-08-09
• Status Verified: 2022-03
• Last Update Submitted: 2022-04-04
• Last Update Posted: 2022-04-12
• Primary Completion: 2024-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15000

Inclusion Criteria

• Myocardial infarction (IDM) 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In-hospital outcomes	Through the end of initial hospitalization, an average of 5 days	To measure the in-hospital major cardiovascular events : recurrence of AMI, myocardial revascularization, stroke
Lipopretein 1 evolution	9 months after the end of initial hospitalization	To evaluate plasma concentrations of Lpa and its dynamic pattern during hospital index and 3-9 months following hospitalization.
In-hospital mortality	Through the end of initial hospitalization, an average of 5 days	In-hospital mortality

Secondary Outcome Measures

Name	Time	Method
Non cardiovascular outcomes during follow-up	Up to 20 years	All cause death and Non-cardiovascular events leading to to hospitalizations
Relationship between patients profile and mortality and cardiovascular morbidity outcomes according to management	Up to 20 years	All cause death and cardiovascular events including non fatal MI, non fatal stroke, revascularization, hospitalization for other cardiovascular causes including Bleeding leading to hospitalization according to patient's management
Oral comorbidities	Up to 20 years	Prevalence of oral pathology and its relationship with early, mid, and long-term prognosis and outcomes
Evaluate the path of care combined with patient care practices following an acute myocardial infarction	Up to 20 years	Evaluate the path of care and patient care practices following an acute myocardial infarction : Reimbursed or prescribed treatments, combined with number of visits, biological and tests performed
Cardiovascular outcomes during follow-up	Up to 20 years	All cause death and Cardiovascular events including non fatal Myocardial Infarction, non fatal stroke, revascularization, hospitalization for other cardiovascular causes including Bleeding leading to hospitalization
Relationship between patients profile and mortality and non-cardiovascular morbidity outcomes according to management	Up to 20 years	All cause death and Non-cardiovascular events leading to to hospitalizations according to patient's management
Sleep disordered breathing comorbidities	Up to 20 years	To assess the prevalence of sleep disordered breathing comorbidities and the relationship with early, mid, and long-term prognosis and outcomes
Evaluate the relevance of European Society of Cardiology (ESC), American Heart Association/American College of Cardiology (AHA / ACC) guidelines regarding management of AMI patients	Up to 20 years	Evaluate the relevance of ESC, AHA/ACC guidelines regarding management of AMI patients
Cost-utility: incremental (or decremental) cost-utility ratio during follow-up	Up to 20 years	Medical care costs for the index hospitalization and during follow-up period are assessed using a combination of resource-based and event-based methods. In-hospital resource utilization are based on diagnosis and procedural codes and length of stay.

Trial Locations

Locations (1)

HEGP; 🇫🇷 Paris, France