Cohort of STEMI Patients 2 (HIBISCUS STEMI)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Myocardial Infarction
• Intervention / Treatment: Other: MRI; Biological: Biocollection; Behavioral: Quality of life questionaries

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas BOCHATON, Dr; Phone Number: +33 04 72 35 75 41; Email: thomas.bochaton@chu-lyon.fr
• Study Contact Backup: Name: Yvonne VARILLON; Phone Number: +33 04 72 35 69 64; Email: yvonne.varillon@chu-lyon.fr

Study Locations

• France
  • Rhone
    • Bron, Rhone, France, 69500
      • Recruiting
      • Hospices civils de Lyon - Hôpital Louis Pradel
      • Contact: Thomas BOCHATON, Dr; Phone Number: +33 04 72 35 75 41; Email: thomas.bochaton@chu-lyon.fr
    • Lyon, Rhone, France, 69004
      • Recruiting
      • Hospices Civils de Lyon - Hôpital de la Croix Rousse
      • Contact: Brahim HARBAOUI, Pr; Phone Number: +33 04 72 35 58 25; Email: brahim.harbaoui@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cohort group; patient with ST-segment elevation myocardial infarction.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2023
• Primary Completion (Estimated): June 3, 2033
• Study Completion (Estimated): June 3, 2033

Study Registration Dates

• First Submitted: February 6, 2023
• First Submitted That Met QC Criteria: March 20, 2023
• First Posted (Actual): March 31, 2023

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: biomarkers; STEMI; Myocardial infarction; clinical outcomes; Imaging markers; bio-collection
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Ischemia; Pathological Conditions, Signs and Symptoms; ST Elevation Myocardial Infarction; Myocardial Infarction
• Other Study ID Numbers: 69HCL22_0991

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No