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NCT Number: NCT05794022

Cohort of STEMI Patients 2

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.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospices Civils de Lyon - Hôpital Louis Pradel, Bron, Rhone, 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
  • 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)

Treatment and study plan

MRI

Other

1 MRI at 1 month with gadolinium injection

Biocollection

Biological

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

Quality of life questionaries

Behavioral

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. Calculation of infarct size on MRI

    Time frame: 1 month

    Measurement of reperfusion lesions on MRI (mass in grams)

  2. Pharmacoepidemiology of myocardial infarction.

    Time frame: 5 years

    Description and evolution of patients' medical treatment between hospital discharge and 5 years follow-up.

  3. Events between inclusion and 5 years follow-up

    Time frame: 5 years

    Time to a major adverse cardiovascular event

Study contacts

Contact information is provided by the study sponsor or research team.

Thomas BOCHATON, Dr

CONTACT

[email protected]

04 72 35 75 41 ext. +33

Yvonne VARILLON

CONTACT

[email protected]

04 72 35 69 64 ext. +33

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
2023
Primary completion
2033
Study completion
2033
First posted
Mar 31, 2023
Registry last updated
May 14, 2026

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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