Cohort of STEMI Patients 2

Myocardial Infarction Clinical Trial

— HIBISCUS STEMI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05794022
• Other study ID #: 69HCL22_0991
• Status: Recruiting
• Phase: N/A
• Start date: May 3, 2023
• Est. completion date: June 3, 2031

Study information

• Verified date: February 2024
• Source: Hospices Civils de Lyon
• Contact: Thomas BOCHATON, Dr
• Phone: 04 72 35 75 41
• Email: thomas.bochaton[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 3, 2031
• Est. primary completion date: June 3, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

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.

Locations

Country	Name	City	State
France	Hospices Civils de Lyon - Hôpital Louis Pradel	Bron	Rhone
France	Hospices Civils de Lyon - Hôpital de la Croix Rousse	Lyon	Rhone

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Research of potential new markers	Biomarkers assays (prognosis and diagnosis) between inclusion and one-year follow-up (H0, H4, H24, H48, M1, M12 since emergency revascularisation)	1 year
Secondary	Calculation of infarct size on MRI	Measurement of reperfusion lesions on MRI (mass in grams)	1 month
Secondary	Pharmacoepidemiology of myocardial infarction.	Description and evolution of patients' medical treatment between hospital discharge and 5 years follow-up.	5 years
Secondary	Events between inclusion and 5 years follow-up	Time to a major adverse cardiovascular event	5 years