CARdiAc Mri and BiOLogical samplEs at the Acute Phase of a Myocardial Infarction (CARAMBOLE)

Study acronym: CARAMBOLE
StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Minor Trial completed
    • Primary and study completion dates changed from estimate of Aug 1, 2026 to Jul 25, 2026
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 8 of 20 entries
  2. Minor Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 150 to confirmed 170
    • Primary and study completion dates: Sep 1, 2026 to Aug 1, 2026
    • Site details revised
    v3
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Primary and study completion dates: Aug 18, 2026 to Sep 1, 2026
    • Start date changed from estimate of Feb 18, 2024 to Mar 1, 2024
    v2
  4. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06278519
Lead Sponsor Poitiers University Hospital
Collaborators: Fédération Française de Cardiologie
Conditions
(from sponsor)
Myocardial Infarction
Related terms Myocardial Infarction
Enrollment 170 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov