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Multicenter Cohort of STEMI Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03070496
Acronym
HIBISCUS-STEMI
Enrollment
281
Registered
2017-03-03
Start date
2017-03-07
Completion date
2023-06-05
Last updated
2025-09-10

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

Conditions

STEMI - ST Elevation Myocardial Infarction

Keywords

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

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).

Interventions

BIOLOGICALBlood sampling

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

PROCEDUREECG

ECG will be performed at 6 months after myocardial infarction

DEVICEMRI

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

OTHERQuality of life questionnaire

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

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

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

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

Design outcomes

Primary

MeasureTime frameDescription
Heart failure stageUp to 3 years after myocardial infarctionHeart failure stage will be assessed thanks to the New York Heart Association (NYHA) classification

Secondary

MeasureTime frameDescription
Infarct size1 month after myocardial infarctionInfarct size will be measured on MRI
Cardiac enzymes rateH0 (admission in coronary angiography room)Cardiac enzymes rate will be analysed in blood samples
EQ-5D score12 month after myocardial infarctionPatients' quality of life will be evaluated thanks to the EQ-5D questionnaire

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026