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Cohort of STEMI Patients 2

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05794022
Acronym
HIBISCUS STEMI
Enrollment
300
Registered
2023-03-31
Start date
2023-05-03
Completion date
2031-06-03
Last updated
2026-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

Keywords

Myocardial infarction, bio-collection, Imaging markers, biomarkers, STEMI, clinical outcomes

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.

Interventions

OTHERMRI

1 MRI at 1 month with gadolinium injection

BIOLOGICALBiocollection

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

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

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Research of potential new markers1 yearBiomarkers assays (prognosis and diagnosis) between inclusion and one-year follow-up (H0, H4, H24, H48, M1, M12 since emergency revascularisation)

Secondary

MeasureTime frameDescription
Calculation of infarct size on MRI1 monthMeasurement of reperfusion lesions on MRI (mass in grams)
Pharmacoepidemiology of myocardial infarction.5 yearsDescription and evolution of patients' medical treatment between hospital discharge and 5 years follow-up.
Events between inclusion and 5 years follow-up5 yearsTime to a major adverse cardiovascular event

Countries

France

Contacts

CONTACTThomas BOCHATON, Dr
thomas.bochaton@chu-lyon.fr04 72 35 75 41
CONTACTYvonne VARILLON
yvonne.varillon@chu-lyon.fr04 72 35 69 64

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026