Multicenter Cohort of STEMI Patients

Study Overview
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Brief Summary
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Ischemic heart disease is the leading cause of mortality with 7.2 million of death in industrialized countries (WHO data). Myocardial infarction corresponding to acute occlusion of a coronary artery is the most brutal form and the more severe ischemic myocardial disease. Every year in France, about 60,000 Myocardial infarctions hospitalized, 30,000 are diagnosed remotely and 30,000 are revealed by an inaugural sudden death. Although mortality from myocardial decreased by 30% over the past decade, the prognosis is pejorative and difficult to assess precisely. The management of the patient depends on these factors, and justifies an active search on these topics, including the mechanisms of the deleterious ventricular remodeling, myocardial inflammation, reperfusion injury which determines in particular the evolution to heart failure. Cohorts of patients with myocardial infarction are rare but can be very valuable by their clinical, laboratory and imaging well documented. They are the source of new hypotheses for research or interventions as well as the quality of care assessment tool. The main objective of this project is to identify new markers: biological and imaging, treatment response and prognosis after acute myocardial infarction. Secondary objectives of the HIBISCUS-STEMI cohort to establish a clinical database, completed by biological samples and by imaging data that can be used in the following areas: Descriptive epidemiology of myocardial infarction and myocardial reperfusion Pharmacoepidemiology and treatments observatory: safety, efficacy, indication of treatment in real life, costs Assessment of the long-term effect of the treatment on the occurrence of heart failure and sudden death Quality of life and personal consequences, family, professional and social myocardial infarction Research of new diagnostic and prognostic biomarkers Research projects (e.g. risk of developing kidney failure or stroke in patients with myocardial infarction compared to the general population).

Official Title
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CoHort of Patients to Identify Biological and Imaging markerS of CardiovascUlar Outcomes in ST Elevation Myocardial Infarction

Conditions
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STEMI - ST Elevation Myocardial Infarction

Intervention / Treatment
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* Biological: Blood sampling
* Procedure: ECG
* Device: MRI
* Other: Quality of life questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years old Diagnosis of STEMI defined by ST segment elevation ≥ 0.2 mV in 2 contiguous leads on a 12-lead ECG. Primary Percutaneous coronary intervention (PCI) Exclusion Criteria: Diagnosis of STEMI not confirmed by angiography Refusal to participate in the study or to sign the consent Impossibility to give information to the subject about the study Lack of medical social coverage Obvious contraindication to magnetic resonance imaging (claustrophobia, pacemaker, defibrillator, renal insufficiency, known allergy to a contrast agent) Deprivation of civil rights participating to another interventional study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STEMI cohort<br>Patients recruited in the cohort will have 4 additional interventions compared to the usual follow-up : an additional blood sampling at 6 months an additional electrocardiogram (ECG) at 6 months Magnetic Resonance Imaging (MRI) Quality of life questionnaire | Biological: Blood sampling<br>* Blood sampling will be performed at 6 months after myocardial infarction to analyse diagnostic and prognostic biomarkers<br>Procedure: ECG<br>* ECG will be performed at 6 months after myocardial infarction<br>Device: MRI<br>* MRI will be performed at 1month after myocardial infarction to analyse ventricular remodeling and reperfusion.<br>Other: Quality of life questionnaire<br>* Patients will pass a quality of life questionnaire at 12 months after myocardial infarction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart failure stage | Heart failure stage will be assessed thanks to the New York Heart Association (NYHA) classification | Up to 3 years after myocardial infarction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infarct size | Infarct size will be measured on MRI | 1 month after myocardial infarction | 
| Cardiac enzymes rate | Cardiac enzymes rate will be analysed in blood samples | H0 (admission in coronary angiography room) | 
| Cardiac enzymes rate | Cardiac enzymes rate will be analysed in blood samples | H4 (4 hours after reperfusion) | 
| Cardiac enzymes rate | Cardiac enzymes rate will be analysed in blood samples | H24 (24 hours after reperfusion) | 
| Cardiac enzymes rate | Cardiac enzymes rate will be analysed in blood samples | H48 (48 hours after reperfusion) | 
| Cardiac enzymes rate | Cardiac enzymes rate will be analysed in blood samples | 1 month after myocardial infarction | 
| Cardiac enzymes rate | Cardiac enzymes rate will be analysed in blood samples | 3 months after myocardial infarction | 
| Cardiac enzymes rate | Cardiac enzymes rate will be analysed in blood samples | 6 months after myocardial infarction | 
| Cardiac enzymes rate | Cardiac enzymes rate will be analysed in blood samples | 12 month after myocardial infarction | 
| EQ-5D score | Patients' quality of life will be evaluated thanks to the EQ-5D questionnaire | 12 month after myocardial infarction | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial infarction, bio-collection, Imaging markers, biomarkers, STEMI, clinical outcomes