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STEMI - ST Elevation Myocardial InfarctionHIBISCUS-STEMINCT03070496

Multicenter Cohort of STEMI Patients

A study testing Blood sampling, ECG and MRI in people with STEMI - ST Elevation Myocardial Infarction, run by Hospices Civils de Lyon at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Blood sampling, ECG and MRI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
281 participants
Where
3 sitesFrance
Study dates
7 Mar 2017to 5 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

France3 sites

  • Hôpital Cardiovasculaire Louis Pradel

    Bron, 69677

  • CHU Strasbourg

    Strasbourg, 67091

  • CHU de Tours

    Tours

Other trials in France

About this study

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

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.

Read more

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).
Being tested
Blood sampling, ECG, MRI, Quality of life questionnaire
Keywords
Myocardial infarction, bio-collection, Imaging markers, biomarkers, STEMI, clinical outcomes
Medical subject headings
ST Elevation Myocardial Infarction, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood samplingBiological

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

  • ECGProcedure or surgery

    ECG will be performed at 6 months after myocardial infarction

  • MRIDevice

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

  • Quality of life questionnaireOther

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

Study groups in NCT03070496
Study groupRoleWhat they receive
STEMI cohortExperimentalPatients recruited in the cohort will have 4 additional interventions compared to the usual follow-up : * an additional blood sampling at 6 months * an additional electrocardiogram (ECG) at 6 months * Magnetic Resonance Imaging (MRI) * Quality of life questionnaire
Receives: Biological: Blood sampling; Procedure: ECG; Device: MRI; Other: Quality of life questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Heart failure stage

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

    Measured: Up to 3 years after myocardial infarction

Secondary outcomes (10)

  1. Infarct size

    Infarct size will be measured on MRI

    Measured: 1 month after myocardial infarction

  2. Cardiac enzymes rate

    Cardiac enzymes rate will be analysed in blood samples

    Measured: H0 (admission in coronary angiography room)

  3. Cardiac enzymes rate

    Cardiac enzymes rate will be analysed in blood samples

    Measured: H4 (4 hours after reperfusion)

  4. Cardiac enzymes rate

    Cardiac enzymes rate will be analysed in blood samples

    Measured: H24 (24 hours after reperfusion)

  5. Cardiac enzymes rate

    Cardiac enzymes rate will be analysed in blood samples

    Measured: H48 (48 hours after reperfusion)

  6. Cardiac enzymes rate

    Cardiac enzymes rate will be analysed in blood samples

    Measured: 1 month after myocardial infarction

  7. Cardiac enzymes rate

    Cardiac enzymes rate will be analysed in blood samples

    Measured: 3 months after myocardial infarction

  8. Cardiac enzymes rate

    Cardiac enzymes rate will be analysed in blood samples

    Measured: 6 months after myocardial infarction

  9. Cardiac enzymes rate

    Cardiac enzymes rate will be analysed in blood samples

    Measured: 12 month after myocardial infarction

  10. EQ-5D score

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

    Measured: 12 month after myocardial infarction

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2017
  2. Study start7 Mar 2017
  3. Primary completion5 Jun 2023
  4. Study completion5 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
281 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03070496
Sponsor's protocol ID
69HCL16_0570
Acronym
HIBISCUS-STEMI
Status last verified
Sep 2025
First submitted
28 Feb 2017
Last updated
10 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Paccalet A, Crola Da Silva C, Mechtouff L, Amaz C, Varillon Y, de Bourguignon C, Cartier R, Prieur C, Tomasevic D, Genot N, Leboube S, Derimay F, Rioufol G, Bonnefoy-Cudraz E, Mewton N, Ovize M, Bidaux G, Bochaton T. Serum Soluble Tumor Necrosis Factor Receptors 1 and 2 Are Early Prognosis Markers After ST-Segment Elevation Myocardial Infarction. Front Pharmacol. 2021 Sep 1;12:656928. doi: 10.3389/fphar.2021.656928. eCollection 2021.

    PubMed 34539391

Questions about this trial

What is this clinical trial studying?

A study testing Blood sampling, ECG and MRI in people with STEMI - ST Elevation Myocardial Infarction, run by Hospices Civils de Lyon at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Heart failure stage (time frame: Up to 3 years after myocardial infarction). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03070496, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.

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