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Completed

NCT Number: NCT03070496

Multicenter Cohort of STEMI Patients

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Cardiovasculaire Louis Pradel, Bron, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling

Biological

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

ECG

Procedure

ECG will be performed at 6 months after myocardial infarction

MRI

Device

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

Quality of Life Questionnaire

Other

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

Primary outcomes

  1. Heart failure stage

    Time frame: Up to 3 years after myocardial infarction

    Heart failure stage will be assessed thanks to the New York Heart Association (NYHA) classification

Secondary outcomes

  1. Infarct size

    Time frame: 1 month after myocardial infarction

    Infarct size will be measured on MRI

  2. Cardiac enzymes rate

    Time frame: H0 (admission in coronary angiography room)

    Cardiac enzymes rate will be analysed in blood samples

  3. Cardiac enzymes rate

    Time frame: H4 (4 hours after reperfusion)

    Cardiac enzymes rate will be analysed in blood samples

  4. Cardiac enzymes rate

    Time frame: H24 (24 hours after reperfusion)

    Cardiac enzymes rate will be analysed in blood samples

  5. Cardiac enzymes rate

    Time frame: H48 (48 hours after reperfusion)

    Cardiac enzymes rate will be analysed in blood samples

  6. Cardiac enzymes rate

    Time frame: 1 month after myocardial infarction

    Cardiac enzymes rate will be analysed in blood samples

  7. Cardiac enzymes rate

    Time frame: 3 months after myocardial infarction

    Cardiac enzymes rate will be analysed in blood samples

  8. Cardiac enzymes rate

    Time frame: 6 months after myocardial infarction

    Cardiac enzymes rate will be analysed in blood samples

  9. Cardiac enzymes rate

    Time frame: 12 month after myocardial infarction

    Cardiac enzymes rate will be analysed in blood samples

  10. EQ-5D score

    Time frame: 12 month after myocardial infarction

    Patients' quality of life will be evaluated thanks to the EQ-5D questionnaire

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: HIBISCUS-STEMI

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Mar 3, 2017
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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