Cohort of STEMI Patients 2

Not Applicable

Recruiting

• Conditions: Myocardial Infarction
• Interventions: Other: MRI; Biological: Biocollection; Behavioral: Quality of life questionaries

• Registration Number: NCT05794022
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-06
• Study First Submitted QC: 2023-03-20
• Study First Posted: 2023-03-31
• Study Start: 2023-05-03
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-06
• Primary Completion: 2031-06-03
• Study Completion: 2031-06-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort group	Biocollection	patient with ST-segment elevation myocardial infarction.
Cohort group	Quality of life questionaries	patient with ST-segment elevation myocardial infarction.
Cohort group	MRI	patient with ST-segment elevation myocardial infarction.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Hospices Civils de Lyon - Hôpital Louis Pradel; 🇫🇷 Bron, Rhone, France

Hospices Civils de Lyon - Hôpital de la Croix Rousse; 🇫🇷 Lyon, Rhone, France