CARdiAc Mri and BiOLogical samplEs at the Acute Phase of a Myocardial Infarction (CARAMBOLE) - Trial NCT06278519

Timeline & Enrollment

Primary Outcome

Major Adverse cardiac Events (MACE)

Summary

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.

ICD-10 Classifications