NCT05794022

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
62mo left

Started May 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress37%
May 2023Jun 2031

First Submitted

Initial submission to the registry

February 6, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 31, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

May 3, 2023

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2031

Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

8.1 years

First QC Date

February 6, 2023

Last Update Submit

January 28, 2026

Conditions

Myocardial Infarction

Keywords

Myocardial infarctionbio-collectionImaging markersbiomarkersSTEMIclinical outcomes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Calculation of infarct size on MRI

    1 month

  • Pharmacoepidemiology of myocardial infarction.

    5 years

  • Events between inclusion and 5 years follow-up

    5 years

Study Arms (1)

Cohort group

OTHER

patient with ST-segment elevation myocardial infarction.

Other: MRIBiological: BiocollectionBehavioral: Quality of life questionaries

Interventions

BiocollectionBIOLOGICAL

Biocollection from blood (H0, H4, H24, H48, 1 month, 1 year), urine (H48) and faecal (initial hospitalisation) samples.

Cohort group
MRIOTHER

1 MRI at 1 month with gadolinium injection

Cohort group
Quality of life questionariesBEHAVIORAL

EQ-5D-5L and HAD questionaries at 1 month and 1 year.

Cohort group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospices Civils de Lyon - Hôpital Louis Pradel

Bron, Rhone, 69500, France

RECRUITING

Hospices Civils de Lyon - Hôpital de la Croix Rousse

Lyon, Rhone, 69004, France

RECRUITING

Related Publications (1)

  • 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: 39579225DERIVED

MeSH Terms

Conditions

Myocardial InfarctionST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Central Study Contacts

Thomas BOCHATON, Dr

CONTACT

04 72 35 75 41thomas.bochaton@chu-lyon.fr

Yvonne VARILLON

CONTACT

04 72 35 69 64yvonne.varillon@chu-lyon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2023

First Posted

March 31, 2023

Study Start

May 3, 2023

Primary Completion (Estimated)

June 3, 2031

Study Completion (Estimated)

June 3, 2031

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)