Multicenter Cohort of STEMI Patients (HIBISCUS-STEMI)

Civil Hospices of Lyon

Status: Completed

Conditions: STEMI - ST Elevation Myocardial Infarction

Treatments: Biological: Blood sampling; Procedure: ECG; Other: Quality of life questionnaire; Device: MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT03070496

69HCL16_0570

Details and patient eligibility

About

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).

Enrollment: 281 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

281 participants in 1 patient group

STEMI cohort

Experimental group

Description:

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

Treatment:

Other: Quality of life questionnaire

Device: MRI

Procedure: ECG

Biological: Blood sampling