Multicenter Cohort of STEMI Patients

Not Applicable

Completed

• Conditions: STEMI - ST Elevation Myocardial Infarction
• Interventions: Biological: Blood sampling; Procedure: ECG; Device: MRI; Other: Quality of life questionnaire

• Registration Number: NCT03070496
• Lead Sponsor: Hospices Civils de Lyon

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-28
• Study First Submitted QC: 2017-02-28
• Study First Posted: 2017-03-03
• Study Start: 2017-03-07
• Primary Completion: 2023-06-05
• Study Completion: 2023-06-05
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-19
• Last Update Posted: 2024-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 281

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
STEMI cohort	MRI	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
STEMI cohort	Quality of life questionnaire	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
STEMI cohort	ECG	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
STEMI cohort	Blood sampling	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

Primary Outcome Measures

Name	Time	Method
Heart failure stage	Up to 3 years after myocardial infarction	Heart failure stage will be assessed thanks to the New York Heart Association (NYHA) classification

Secondary Outcome Measures

Name	Time	Method
Infarct size	1 month after myocardial infarction	Infarct size will be measured on MRI
Cardiac enzymes rate	12 month after myocardial infarction	Cardiac enzymes rate will be analysed in blood samples
EQ-5D score	12 month after myocardial infarction	Patients' quality of life will be evaluated thanks to the EQ-5D questionnaire

Trial Locations

Locations (3)

Hôpital Cardiovasculaire Louis Pradel; 🇫🇷 Bron, France

CHU de Tours; 🇫🇷 Tours, France

CHU Strasbourg; 🇫🇷 Strasbourg, France