NCT06278519Completed
CARdiAc Mri and BiOLogical samplEs at the Acute Phase of a Myocardial Infarction (CARAMBOLE)
Cardiac MRI and Biological Samples at the Acute Phase of a Myocardial Infarction
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
ST-Segment Elevation Myocardial infarction (STEMI) corresponding to acute occlusion of cornary artery is the most severe ischemic myocardial disease and a leading cause of mortality of heart failure worldwide. Although acute mortality from STEMI has decreased over the last decades, the prognosis remains pejorative and difficult to anticipate. The best management of STEMI patients depends of predictive factors of clinical prognosis and justifies an active research of these factors, in particular the mechanisms leading to deleterious left ventricular remodeling, myocardial inflammation, reperfusion injury including the no-reflow phenomenon which is a major determinant of heart failure. Cohorts of consecutive STEMI patients, with a comprehensive assessment of clinical, biological and imaging parameters are needed to offer the basis for new hypothese for research or interventions and to precisely evaluate the quality of care provided. The main objective of this study is to identify new markers: clinical, biological and imaging, treatment response and prognosis after STEMI. Secondary objectives of the CARAMBOLE cohort are to establish a comprehensive clinical databse, completed with biological samples and imaging data, that can be used in the following areas: * Descriptive epidemiology of STEMI and myocardial reperfusion * Evaluation of the clinical implications of the realization of a cardiac MRI at the acute phase of STEMI (regarding no-reflow, LVEF, intra cardiac thrombi) * Treatments observatory: safety, efficacy, indication of treatments provided in real life compared to the treatments recommended, adherence to treatments, costs * Quality of life, personal, familial, social and professional consequences of myocardial infarction * Research of new diagnostic and prognosis biomarkers * Research projects (e.g risk of developping cgnitive disorders in patients with STEMI as compared to the general population) Participants will undergo: * a cardiac MRI at the acute phase of their STEMI (5 +/- 3 days) then at 1 year follow-up * biological samples including blood, urinary and feces samples, at the acute phase of their STEMI (from admission and up to 8 days) then at 1 year follow-up * questionnaire assessment regarding their quality of life, cognitive status,and socio-economic conditions at the acute phase and 1 year follow-up of their STEMI.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 170 (actual)
- First submitted
- 19 Dec 2023
- Start date
- 1 Mar 2024
- Primary completion date
- 25 Jul 2026
- Lead sponsor
- Poitiers University Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT06278519
What you commit to
- Study type: Interventional
- Participants enrolled: 170
- From 1 Mar 2024 to the primary completion date, 25 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in another interventional study with an investigational drug or device, which, in the judgment of the investigator, could interfere with the present study
Other illness
- Subject with contraindication to MRI : pregnancy, ocular metallic foreign body (accidental or other chips), pace-maker incompatible with MRI, foreign ferromagnetic ocular or cerebral bodies, cochlear implants and in general all electronic medical material immovably implanted and incompatible with MRI; metallic heart valve of 1st generation, vascular clips formerly implanted on cranial aneurysm, severe renal insufficiency
- Hypersensitivity to gadoteric acid, to meglumine or to a drug containing gadolinium
Other
- Patient suffering from claustrophobia
- patients with insufficient venous access for contrast medium injection.
- Patients not benefiting from a Social Security scheme or not benefiting from it through a third party
- Persons benefitting from enhanced protection, namely minors, pregnant women, persons deprived of their liberty by a judicial or administrative decision, patients staying in a health or social establishment, adults under legal protection
Who the study is looking for
- Patient ≥18 years old, hospitalised in cardiology departments at the C.H.U. of Poitiers
- Myocardial infarction type 1, 2 or 3 according to the 4th universal definition, with elevation of ST segment ≥0.2 milliVolt in two contiguous derivations of the ECG.
- Patient able to comply with study procedures
- Patient legally free and not subject to any custody, guardianship, tutelage or subordination measures
- Informed consent signed by the patient/relative or trusted person after clear and complete information about the clinical investigation.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| C.H.U. of Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.