Myocardial InfarctionHIBISCUS STEMINCT05794022
Cohort of STEMI Patients 2
A study testing MRI, Biocollection and Quality of life questionaries in people with Myocardial Infarction, run by Hospices Civils de Lyon at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- MRI, Biocollection and Quality of life questionaries
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesFrance
- Study dates
- 3 May 2023to 3 Jun 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Hospices Civils de Lyon - Hôpital Louis Pradel
Bron, Rhone, 69500
Thomas BOCHATON, Dr, 04 72 35 75 41 ext. +33, thomas.bochaton@chu-lyon.fr
- Recruiting
Hospices Civils de Lyon - Hôpital de la Croix Rousse
Lyon, Rhone, 69004
Brahim HARBAOUI, Pr, 04 72 35 58 25 ext. +33, brahim.harbaoui@chu-lyon.fr
About this study
Official title: CoHort of Patients to Identify Biological and Imaging markerS of CardiovascUlar Outcomes in ST Elevation Myocardial Infarction
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.
- Conditions
- Myocardial Infarction
- Being tested
- MRI, Biocollection, Quality of life questionaries
- Keywords
- Myocardial infarction, bio-collection, Imaging markers, biomarkers, STEMI, clinical outcomes
- Medical subject headings
- Myocardial Infarction, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
1 MRI at 1 month with gadolinium injection
BiocollectionBiological
Biocollection from blood (H0, H4, H24, H48, 1 month, 1 year), urine (H48) and faecal (initial hospitalisation) samples.
Quality of life questionariesBehavioural
EQ-5D-5L and HAD questionaries at 1 month and 1 year.
| Study group | Role | What they receive |
|---|---|---|
| Cohort group | Other | patient with ST-segment elevation myocardial infarction. Receives: Other: MRI; Biological: Biocollection; Behavioral: Quality of life questionaries |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 year
Secondary outcomes (3)
Calculation of infarct size on MRI
Measurement of reperfusion lesions on MRI (mass in grams)
Measured: 1 month
Pharmacoepidemiology of myocardial infarction.
Description and evolution of patients' medical treatment between hospital discharge and 5 years follow-up.
Measured: 5 years
Events between inclusion and 5 years follow-up
Time to a major adverse cardiovascular event
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start3 May 2023
- Primary completion3 Jun 2033 (estimated)
- Study completion3 Jun 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05794022
- Sponsor's protocol ID
- 69HCL22_0991
- Acronym
- HIBISCUS STEMI
- Status last verified
- Jan 2026
- First submitted
- 6 Feb 2023
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stevic N, Pinede A, Mewton N, Ovize M, Argaud L, Lecour S, Boiteux C, Bochaton T, Cour M. Effect of ventricular fibrillation on infarct size after myocardial infarction: a translational study. Basic Res Cardiol. 2024 Dec;119(6):911-921. doi: 10.1007/s00395-024-01091-9. Epub 2024 Nov 23.
PubMed 39579225
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CoHort of Patients to Identify Biological and Imaging markerS of CardiovascUlar Outcomes in ST Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT05794022
- Acronym / sponsor ID
- HIBISCUS STEMI / 69HCL22_0991
- Conditions
- Myocardial Infarction
- Keywords
- Myocardial infarction, bio-collection, Imaging markers, biomarkers, STEMI, clinical outcomes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 3 May 2023 (actual)
- Primary completion
- 3 Jun 2033 (estimated)
- Study completion
- 3 Jun 2033 (estimated)
- First posted
- 31 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort group | Other | Other: MRI, Biological: Biocollection, Behavioral: Quality of life questionariespatient with ST-segment elevation myocardial infarction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI1 MRI at 1 month with gadolinium injection | Other | Cohort group |
| BiocollectionBiocollection from blood (H0, H4, H24, H48, 1 month, 1 year), urine (H48) and faecal (initial hospitalisation) samples. | Biological | Cohort group |
| Quality of life questionariesEQ-5D-5L and HAD questionaries at 1 month and 1 year. | Behavioural | Cohort group |
Primary outcome
Research of potential new markers
Time frame: 1 year
Biomarkers assays (prognosis and diagnosis) between inclusion and one-year follow-up (H0, H4, H24, H48, M1, M12 since emergency revascularisation)
3 secondary outcomes
Calculation of infarct size on MRI
Time frame: 1 month
Pharmacoepidemiology of myocardial infarction.
Time frame: 5 years
Events between inclusion and 5 years follow-up
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Derived from this study: PubMed 39579225Stevic N, Pinede A, Mewton N, Ovize M, Argaud L, Lecour S, Boiteux C, Bochaton T, Cour M. Effect of ventricular fibrillation on infarct size after myocardial infarction: a translational study. Basic Res Cardiol. 2024 Dec;119(6):911-921. doi: 10.1007/s00395-024-01091-9. Epub 2024 Nov 23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI, Biocollection and Quality of life questionaries in people with Myocardial Infarction, run by Hospices Civils de Lyon at 2 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas BOCHATON, Dr (04 72 35 75 41 ext. +33, thomas.bochaton@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Research of potential new markers (time frame: 1 year). 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 NCT05794022, 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 14 May 2026.