Multicenter Cohort of STEMI Patients

NCT ID: NCT03070496

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 281 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-07
• Study Completion Date: 2023-06-05

Brief Summary

Ischemic heart disease is the leading cause of mortality with 7.2 million of death in industrialized countries (WHO data). Myocardial infarction corresponding to acute occlusion of a coronary artery is the most brutal form and the more severe ischemic myocardial disease. Every year in France, about 60,000 Myocardial infarctions hospitalized, 30,000 are diagnosed remotely and 30,000 are revealed by an inaugural sudden death. Although mortality from myocardial decreased by 30% over the past decade, the prognosis is pejorative and difficult to assess precisely. The management of the patient depends on these factors, and justifies an active search on these topics, including the mechanisms of the deleterious ventricular remodeling, myocardial inflammation, reperfusion injury which determines in particular the evolution to heart failure. Cohorts of patients with myocardial infarction are rare but can be very valuable by their clinical, laboratory and imaging well documented. They are the source of new hypotheses for research or interventions as well as the quality of care assessment tool.

The main objective of this project is to identify new markers: biological and imaging, treatment response and prognosis after acute myocardial infarction.

Secondary objectives of the HIBISCUS-STEMI cohort to establish a clinical database, completed by biological samples and by imaging data that can be used in the following areas:

• Descriptive epidemiology of myocardial infarction and myocardial reperfusion
• Pharmacoepidemiology and treatments observatory: safety, efficacy, indication of treatment in real life, costs
• Assessment of the long-term effect of the treatment on the occurrence of heart failure and sudden death
• Quality of life and personal consequences, family, professional and social myocardial infarction
• Research of new diagnostic and prognostic biomarkers
• Research projects (e.g. risk of developing kidney failure or stroke in patients with myocardial infarction compared to the general population).

Conditions

STEMI - ST Elevation Myocardial Infarction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

STEMI cohort

Patients recruited in the cohort will have 4 additional interventions compared to the usual follow-up :

• an additional blood sampling at 6 months
• an additional electrocardiogram (ECG) at 6 months
• Magnetic Resonance Imaging (MRI)
• Quality of life questionnaire

Group Type: EXPERIMENTAL

Blood sampling

Intervention Type: BIOLOGICAL

Blood sampling will be performed at 6 months after myocardial infarction to analyse diagnostic and prognostic biomarkers

ECG

Intervention Type: PROCEDURE

ECG will be performed at 6 months after myocardial infarction

MRI

Intervention Type: DEVICE

MRI will be performed at 1month after myocardial infarction to analyse ventricular remodeling and reperfusion.

Quality of life questionnaire

Intervention Type: OTHER

Patients will pass a quality of life questionnaire at 12 months after myocardial infarction

Interventions

Blood sampling

Blood sampling will be performed at 6 months after myocardial infarction to analyse diagnostic and prognostic biomarkers

Intervention Type: BIOLOGICAL

ECG

ECG will be performed at 6 months after myocardial infarction

Intervention Type: PROCEDURE

MRI

MRI will be performed at 1month after myocardial infarction to analyse ventricular remodeling and reperfusion.

Intervention Type: DEVICE

Quality of life questionnaire

Patients will pass a quality of life questionnaire at 12 months after myocardial infarction

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age > 18 years old
• Diagnosis of STEMI defined by ST segment elevation ≥ 0.2 mV in 2 contiguous leads on a 12-lead ECG.
• Primary Percutaneous coronary intervention (PCI)

Exclusion Criteria

• Diagnosis of STEMI not confirmed by angiography
• Refusal to participate in the study or to sign the consent
• Impossibility to give information to the subject about the study
• Lack of medical social coverage
• Obvious contraindication to magnetic resonance imaging (claustrophobia, pacemaker, defibrillator, renal insufficiency, known allergy to a contrast agent)
• Deprivation of civil rights
• participating to another interventional study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michel OVIZE, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Hôpital Cardiovasculaire Louis Pradel

Bron, , France

CHU Strasbourg

Strasbourg, , France

CHU de Tours

Tours, , France

Countries

France

References

Paccalet A, Crola Da Silva C, Mechtouff L, Amaz C, Varillon Y, de Bourguignon C, Cartier R, Prieur C, Tomasevic D, Genot N, Leboube S, Derimay F, Rioufol G, Bonnefoy-Cudraz E, Mewton N, Ovize M, Bidaux G, Bochaton T. Serum Soluble Tumor Necrosis Factor Receptors 1 and 2 Are Early Prognosis Markers After ST-Segment Elevation Myocardial Infarction. Front Pharmacol. 2021 Sep 1;12:656928. doi: 10.3389/fphar.2021.656928. eCollection 2021.

Reference Type: BACKGROUND

PMID: 34539391 (View on PubMed)

Other Identifiers

69HCL16_0570

Identifier Type: -

Identifier Source: org_study_id