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

NCT06278519 | Active Not Recruiting

• 1 other identifier: CARAMBOLE
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myocardial Infarction

Keywords

cardiology

Outcome Measures

Primary Outcomes (1)

• Major Adverse cardiac Events (MACE)

  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

  Up to 1 year after STEMI

Secondary Outcomes (20)

• Infarct size

  Up to 8 days after STEMI

• Infarct size

  1 year follow-up after STEMI

• No-reflow size

  Up to 8 days after STEMI

• No-reflow size

  1 year follow-up after STEMI

• Cardiac enzymes rate

  H0 (admission in Intensive Cardiac Care Unit)

Study Arms (1)

Blood and urinary collection, cardiac MRI

EXPERIMENTAL

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

Biological: Blood, urinary and feces collection; Device: Cardiac MRI; Other: Quality of life and cognitive status questionnaire

Interventions

Blood, urinary and feces collection BIOLOGICAL

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

Blood and urinary collection, cardiac MRI

Cardiac MRI DEVICE

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

Blood and urinary collection, cardiac MRI

Quality of life and cognitive status questionnaire OTHER

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

Blood and urinary collection, cardiac MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Patient suffering from claustrophobia
• Hypersensitivity to gadoteric acid, to meglumine or to a drug containing gadolinium
• patients with insufficient venous access for contrast medium injection.
• Participation in another interventional study with an investigational drug or device, which, in the judgment of the investigator, could interfere with the present study
• 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

Sponsors & Collaborators

• Poitiers University Hospital: lead
• Fédération Française de Cardiologie: collaborator

Study Sites (1)

C.H.U. of Poitiers

Poitiers, 86000, France

Location

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Blood Specimen Collection; Quality of Life

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: February 26, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 6, 2025

Record last verified: 2025-08

Locations

FR (1)