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Cohort of STEMI Patients 2

ConditionMyocardial Infarction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospices Civils de Lyon

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 ....)

Trial design

Design model

Single group

Treatments tested in this trial

  • MRI

    Other intervention

    1 MRI at 1 month with gadolinium injection

  • Biocollection

    Biological/Vaccine

    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.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Cohort groupOther 3 interventions

Trial outcomes

Primary outcomes

1

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)

Time frame
1 year

Secondary outcomes

1

Calculation of infarct size on MRI

Measurement of reperfusion lesions on MRI (mass in grams)

Time frame
1 month
2

Pharmacoepidemiology of myocardial infarction.

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

Time frame
5 years
3

Events between inclusion and 5 years follow-up

Time to a major adverse cardiovascular event

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospices Civils de Lyon

Lead sponsor

Source ClinicalTrials.gov
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