French Cohort of Myocardial Infarction Evaluation

Study Overview
=================
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.

Official Title
-----------------
French Cohort of Myocardial Infarction Evaluation

Conditions
-----------------
Acute Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Myocardial infarction<br>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 | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular outcomes during follow-up | 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 | Up to 20 years | 
| Non cardiovascular outcomes during follow-up | All cause death and Non-cardiovascular events leading to to hospitalizations | Up to 20 years | 
| Relationship between patients profile and mortality and cardiovascular morbidity outcomes according to management | 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 | Up to 20 years | 
| Relationship between patients profile and mortality and non-cardiovascular morbidity outcomes according to management | All cause death and Non-cardiovascular events leading to to hospitalizations according to patient's management | Up to 20 years | 
| Oral comorbidities | Prevalence of oral pathology and its relationship with early, mid, and long-term prognosis and outcomes | Up to 20 years | 
| Sleep disordered breathing comorbidities | To assess the prevalence of sleep disordered breathing comorbidities and the relationship with early, mid, and long-term prognosis and outcomes | Up to 20 years | 
| Evaluate the path of care combined with patient care practices following an acute myocardial infarction | 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 | 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 | Evaluate the relevance of ESC, AHA/ACC guidelines regarding management of AMI patients | Up to 20 years | 
| Cost-utility: incremental (or decremental) cost-utility ratio during follow-up | 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. | Up to 20 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Myocardial Infarction, Registry, Outcomes, Medico-economic evaluation, Comorbidities