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

Condition(s) studied

Investigational drug(s) / intervention(s)

Blood, urinary and feces collection: Blood, urinary and feces collection, at inclusion during acute phase of STEMI, and one year after inclusion visit.

Cardiac MRI: Cardiac MRI at the acute phase of STEMI (Day 5 +/- 3) and at 1-year follow-up

Quality of life and cognitive status questionnaire: Quality of life and cognitive status questionnaire at the acute phase of STEMI and at 1-year follow-up

Study 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.

Eligibility

Primary outcome measure(s)

• Major Adverse cardiac Events (MACE) — Up to 1 year after STEMI
  MACE (death, recurrence of myocardial infarction, ischemic stroke, hospitalization for heart failure, unplanned coronary revascularization) will be assessed through medical records and clinical follow-up

Trial sites (1)

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