Clinical trial NCT03070496: Multicenter Cohort of STEMI Patients
Official title: CoHort of Patients to Identify Biological and Imaging markerS of CardiovascUlar Outcomes in ST Elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: STEMI - ST Elevation Myocardial Infarction
Keywords: Myocardial infarction
bio-collection
Imaging markers
biomarkers
STEMI
clinical outcomes
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-03-03
Enrollment: 281
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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).


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

Primary outcomes:
measure: Heart failure stage
timeFrame: Up to 3 years after myocardial infarction
Secondary outcomes:
measure: Infarct size
timeFrame: 1 month after myocardial infarction
measure: Cardiac enzymes rate
timeFrame: H0 (admission in coronary angiography room)
measure: Cardiac enzymes rate
timeFrame: H4 (4 hours after reperfusion)
measure: Cardiac enzymes rate
timeFrame: H24 (24 hours after reperfusion)
measure: Cardiac enzymes rate
timeFrame: H48 (48 hours after reperfusion)
measure: Cardiac enzymes rate
timeFrame: 1 month after myocardial infarction
measure: Cardiac enzymes rate
timeFrame: 3 months after myocardial infarction
measure: Cardiac enzymes rate
timeFrame: 6 months after myocardial infarction
measure: Cardiac enzymes rate
timeFrame: 12 month after myocardial infarction
measure: EQ-5D score
timeFrame: 12 month after myocardial infarction
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Cardiovasculaire Louis Pradel
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Tours
country: France
facility: CHU de Tours
Study officials:
affiliation: Hospices Civils de Lyon
name: Michel OVIZE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: