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Recruiting NCT05794022

Cohort of STEMI Patients 2

No phase Interventional Myocardial Infarction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MRI, Biocollection, Quality of life questionaries.
Who it may be relevant to
Registry conditions: Myocardial Infarction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Other MRI
    1 MRI at 1 month with gadolinium injection
  • Biological Biocollection
    Biocollection from blood (H0, H4, H24, H48, 1 month, 1 year), urine (H48) and faecal (initial hospitalisation) samples.
  • Behavioral Quality of life questionaries
    EQ-5D-5L and HAD questionaries at 1 month and 1 year.

Primary outcome measures

  • Research of potential new markers [Time frame: 1 year]
Secondary outcome measures (3)
  • Calculation of infarct size on MRI [Time frame: 1 month]
  • Pharmacoepidemiology of myocardial infarction. [Time frame: 5 years]
  • Events between inclusion and 5 years follow-up [Time frame: 5 years]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 2 centers
  • Hospices Civils de Lyon - Hôpital Louis Pradel — Bron
  • Hospices Civils de Lyon - Hôpital de la Croix Rousse — Lyon

Publications

  • Stevic N, Pinede A, Mewton N, Ovize M, Argaud L, Lecour S, Boiteux C, Bochaton T, Cour M. Effect of ventricular fibrillation on infarct size after myocardial infarction: a translational study. Basic Res Cardiol. 2024 Dec;119(6):911-921. doi: 10.1007/s00395-024-01091-9. Epub 2024 Nov 23. PMID 39579225

Identifiers

NCT: NCT05794022 · 69HCL22_0991

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗