HIBISCUS STEMI: Cohort of STEMI Patients 2

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05794022

Collaborator

(none)

100

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

ST-segment elevation myocardial infarction (STEMI) is an acute condition that accounts for 75% of sudden deaths in adults over 35 years of age and more than half of all cases of chronic heart failure. However, the mechanism of myocardial infarction remains poorly understood. At present, there is no national information system for myocardial infarction, as there is for other diseases such as multiple sclerosis (OFSEP cohort).

The purpose of this cohort is to enable studies and research projects to be carried out on the descriptive epidemiology of myocardial infarction, monitoring of patients undergoing treatment (safety, efficacy), quality of life and functional consequences of infarction, and research into new biological and imaging prognostic biomarkers. Its general objective is to provide researchers, hospital practitioners, medical interns, academics or industrialists with a quality epidemiological tool for research.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction	Other: MRI Biological: Biocollection Behavioral: Quality of life questionaries	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: Cohort group patient with ST-segment elevation myocardial infarction.	Other: MRI 1 MRI at 1 month with gadolinium injection Biological: Biocollection Biocollection from blood (H0, H4, H24, H48, 1 month, 1 year), urine (H48) and faecal (initial hospitalisation) samples. Behavioral: Quality of life questionaries EQ-5D-5L and HAD questionaries at 1 month and 1 year.

Arm

Intervention/Treatment

Other: Cohort group

patient with ST-segment elevation myocardial infarction.

Other: MRI

1 MRI at 1 month with gadolinium injection

Biological: Biocollection

Biocollection from blood (H0, H4, H24, H48, 1 month, 1 year), urine (H48) and faecal (initial hospitalisation) samples.

Behavioral: Quality of life questionaries

EQ-5D-5L and HAD questionaries at 1 month and 1 year.

Outcome Measures

Primary Outcome Measures

Research of potential new markers [1 year]
Biomarkers assays (prognosis and diagnosis) between inclusion and one-year follow-up (H0, H4, H24, H48, M1, M12 since emergency revascularisation)

Secondary Outcome Measures

Calculation of infarct size on MRI [1 month]
Measurement of reperfusion lesions on MRI (mass in grams)
Pharmacoepidemiology of myocardial infarction. [5 years]
Description and evolution of patients' medical treatment between hospital discharge and 5 years follow-up.
Events between inclusion and 5 years follow-up [5 years]
Time to a major adverse cardiovascular event

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥ 18 years
Diagnosis of STEMI defined by ST segment elevation ≥ 0.2 mV in 2 contiguous leads on a 12-lead ECG.
Management in primary ACT
Prior oral informed consent followed by signed informed consent as soon as possible.

Exclusion Criteria:

Diagnosis of STEMI not confirmed on angiography
Inability to give the subject informed information
Lack of coverage by a social security scheme
Obvious contraindication to injected magnetic resonance imaging (claustrophobia, pacemaker, defibrillator, or a metallic body (ferromagnetic), severe renal insufficiency (GFR<30 ml/min), known allergy to the contrast medium ....)
Pregnant woman or woman of childbearing age without effective contraception, breastfeeding woman.
Deprivation of civil rights (curators, guardianship, safeguard of justice)