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Clinical Trials/NCT05794022
NCT05794022
Recruiting
Not Applicable

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

Hospices Civils de Lyon2 sites in 1 country300 target enrollmentMay 3, 2023

Overview

Phase
Not Applicable
Intervention
MRI
Conditions
Myocardial Infarction
Sponsor
Hospices Civils de Lyon
Enrollment
300
Locations
2
Primary Endpoint
Research of potential new markers
Status
Recruiting
Last Updated
3 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 3, 2023
End Date
June 3, 2031
Last Updated
3 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Arms & Interventions

Cohort group

patient with ST-segment elevation myocardial infarction.

Intervention: MRI

Cohort group

patient with ST-segment elevation myocardial infarction.

Intervention: Biocollection

Cohort group

patient with ST-segment elevation myocardial infarction.

Intervention: Quality of life questionaries

Outcomes

Primary Outcomes

Research of potential new markers

Time Frame: 1 year

Biomarkers assays (prognosis and diagnosis) between inclusion and one-year follow-up (H0, H4, H24, H48, M1, M12 since emergency revascularisation)

Secondary Outcomes

  • Pharmacoepidemiology of myocardial infarction.(5 years)
  • Calculation of infarct size on MRI(1 month)
  • Events between inclusion and 5 years follow-up(5 years)

Study Sites (2)

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