Cohort of STEMI Patients 2

Study Overview
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Brief Summary
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ST-segment elevation myocardial infarction (STEMI) is an acute condition that accounts for 75% of sudden deaths in adults over 35 years of age and more than half of all cases of chronic heart failure. However, the mechanism of myocardial infarction remains poorly understood. At present, there is no national information system for myocardial infarction, as there is for other diseases such as multiple sclerosis (OFSEP cohort). The purpose of this cohort is to enable studies and research projects to be carried out on the descriptive epidemiology of myocardial infarction, monitoring of patients undergoing treatment (safety, efficacy), quality of life and functional consequences of infarction, and research into new biological and imaging prognostic biomarkers. Its general objective is to provide researchers, hospital practitioners, medical interns, academics or industrialists with a quality epidemiological tool for research.

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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Myocardial Infarction

Intervention / Treatment
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* Other: MRI
* Biological: Biocollection
* Behavioral: Quality of life questionaries


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Diagnosis of STEMI defined by ST segment elevation ≥ 0.2 mV in 2 contiguous leads on a 12-lead ECG. Management in primary ACT Prior oral informed consent followed by signed informed consent as soon as possible. Exclusion Criteria: Diagnosis of STEMI not confirmed on angiography Inability to give the subject informed information Lack of coverage by a social security scheme Obvious contraindication to injected magnetic resonance imaging (claustrophobia, pacemaker, defibrillator, or a metallic body (ferromagnetic), severe renal insufficiency (GFR<30 ml/min), known allergy to the contrast medium ....) Pregnant woman or woman of childbearing age without effective contraception, breastfeeding woman. Deprivation of civil rights (curators, guardianship, safeguard of justice)

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cohort group<br>patient with ST-segment elevation myocardial infarction. | Other: MRI<br>* 1 MRI at 1 month with gadolinium injection<br>Biological: Biocollection<br>* Biocollection from blood (H0, H4, H24, H48, 1 month, 1 year), urine (H48) and faecal (initial hospitalisation) samples.<br>Behavioral: Quality of life questionaries<br>* EQ-5D-5L and HAD questionaries at 1 month and 1 year.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Research of potential new markers | Biomarkers assays (prognosis and diagnosis) between inclusion and one-year follow-up (H0, H4, H24, H48, M1, M12 since emergency revascularisation) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calculation of infarct size on MRI | Measurement of reperfusion lesions on MRI (mass in grams) | 1 month | 
| Pharmacoepidemiology of myocardial infarction. | Description and evolution of patients' medical treatment between hospital discharge and 5 years follow-up. | 5 years | 
| Events between inclusion and 5 years follow-up | Time to a major adverse cardiovascular event | 5 years | 

 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