HIBISCUS-STEMI: Multicenter Cohort of STEMI Patients

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Recruiting

CT.gov ID

NCT03070496

Collaborator

(none)

281

Enrollment

Locations

Arm

Anticipated Duration (Months)

93.7

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
STEMI - ST Elevation Myocardial Infarction	Biological: Blood sampling Procedure: ECG Device: MRI Other: Quality of life questionnaire	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

281 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Mar 7, 2017

Anticipated Primary Completion Date :

Dec 7, 2022

Anticipated Study Completion Date :

Dec 7, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Biological: Blood sampling Blood sampling will be performed at 6 months after myocardial infarction to analyse diagnostic and prognostic biomarkers Procedure: ECG ECG will be performed at 6 months after myocardial infarction Device: MRI MRI will be performed at 1month after myocardial infarction to analyse ventricular remodeling and reperfusion. Other: Quality of life questionnaire Patients will pass a quality of life questionnaire at 12 months after myocardial infarction

Arm

Intervention/Treatment

Experimental: 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

Biological: Blood sampling

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

Procedure: ECG

ECG will be performed at 6 months after myocardial infarction

Device: MRI

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

Other: Quality of life questionnaire

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

Outcome Measures

Primary Outcome Measures

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

Infarct size [1 month after myocardial infarction]
Infarct size will be measured on MRI
Cardiac enzymes rate [H0 (admission in coronary angiography room)]
Cardiac enzymes rate will be analysed in blood samples
Cardiac enzymes rate [H4 (4 hours after reperfusion)]
Cardiac enzymes rate will be analysed in blood samples
Cardiac enzymes rate [H24 (24 hours after reperfusion)]
Cardiac enzymes rate will be analysed in blood samples
Cardiac enzymes rate [H48 (48 hours after reperfusion)]
Cardiac enzymes rate will be analysed in blood samples
Cardiac enzymes rate [1 month after myocardial infarction]
Cardiac enzymes rate will be analysed in blood samples
Cardiac enzymes rate [3 months after myocardial infarction]
Cardiac enzymes rate will be analysed in blood samples
Cardiac enzymes rate [6 months after myocardial infarction]
Cardiac enzymes rate will be analysed in blood samples
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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