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

Cardiac MRI and Biological Samples at the Acute Phase of a Myocardial Infarction

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.

Study Overview

• Status: Recruiting
• Conditions: Myocardial Infarction
• Intervention / Treatment: Biological: Blood, urinary and feces collection; Device: Cardiac MRI; Other: Quality of life and cognitive status questionnaire

Detailed Description

Myocardial infarction is one of the leading causes of morbi-mortality, causing 75% of cases of sudden death in adults over 35 years of age and more than half of chronic heart failure. Despite the progress made, based on French data from the CIRCUS study and the FAST-MI registry, all-cause mortality at 1 year remained high at around 8% and the rate of occurrence of composite events (death, heart failure, myocardial infarction, revascularization, stroke) estimated around 25%. ST-segment elevation myocardial infarction (STEMI) is the most severe form of ischemic myocardial disease. The recommended treatment is the quickest possible unblocking of the coronary artery responsible for STEMI, by coronary angioplasty (treatment of choice if time limits are compatible) or, more rarely, thrombolysis. However, this revascularization causes undesirable collateral effects with tissue edema, intra-myocardial hemorrhages, microvascular obstruction and local inflammation which contribute to significantly aggravate myocardial damage. These "reperfusion injuries" increase the risk of Left Ventricular (LV) dysfunction. Thus, immediate mortality decreases but the incidence of heart failure following STEMI increases. Several other parameters associated with a poor prognosis remain to this day incompletely understood and treated: deleterious left ventricular remodeling (LVR), post-infarction inflammation, no-reflow.

Furthermore, performing a systematic MRI at the acute phase of STEMI will allow to assess the real prevalence of intra LV thrombi and to treat them before hospital discharge. Indeed, the prevalence of intraLV thrombi is estimated around 20% but only 16% are diagnosed during the stay in the Cardiology Intensive Care Unit (CICU) (low sensitivity of echocardiography, lack of availability of cardiac MRI) . These patients must be treated with anticoagulants to limit the embolic phenomena of intra LV thrombi, in particular strokes, but most patients therefore do not benefit from this treatment when leaving the hospital since MRI is not performed in the acute phase in most centers due to lack of availability.

The organization of prospective cohorts with well-documented biological and imaging collections, in particular the systematic use of myocardial MRI, and monitoring of events at 1 year, will thus make it possible to better understand the complex pathophysiology of these deleterious phenomena, their clinical consequences, to propose research hypotheses and ultimately, to developp innovative and personalized treatments.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Claire BOULETI, MD; Phone Number: +33 5 49 44 43 25; Email: claire.bouleti@chu-poitiers.fr
• Study Contact Backup: Name: Corinne Lorrain; Phone Number: +33 5 49 44 39 30; Email: corinne.lorrain@chu-poitiers.fr

Study Locations

• France
  • Poitiers, France, 86000
    • Recruiting
    • C.H.U. of Poitiers
    • Contact: Claire BOULETI, MD; Phone Number: +33 5 49 44 43 25; Email: claire.bouleti@chu-poitiers.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Blood and urinary collection, cardiac MRI; 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; Blood, urinary and feces collection, at inclusion during acute phase of STEMI, and one year after inclusion visit.; Device: Cardiac MRI; Cardiac MRI at the acute phase of STEMI (Day 5 +/- 3) and at 1-year follow-up; Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infarct size	Infarct size will be measured on Cardiac MRI	Up to 8 days after STEMI
Infarct size	Infarct size will be measured on Cardiac MRI	1 year follow-up after STEMI
No-reflow size	No-reflow size will be measured on Cardiac MRI	Up to 8 days after STEMI
No-reflow size	No-reflow size will be measured on Cardiac MRI	1 year follow-up after STEMI
Cardiac enzymes rate	Cardiac enzymes rate will be analyzed on blood samples	H0 (admission in Intensive Cardiac Care Unit)
Cardiac enzymes rate	Cardiac enzymes rate will be analyzed on blood samples	H24 (24 hours after reperfusion)
Cardiac enzymes rate	Cardiac enzymes rate will be analyzed on blood samples	H48 (48 hours after reperfusion)
Cardiac enzymes rate	Cardiac enzymes rate will be analyzed on blood samples	1 year follow-up after STEMI
Inflammatory markers rate	Inflammatory markers rate will be analyzed on blood samples	H0 (admission in Intensive Cardiac Care Unit)
Inflammatory markers rate	Inflammatory markers rate will be analyzed on blood samples	H24 (24 hours after reperfusion)
Inflammatory markers rate	Inflammatory markers rate will be analyzed on blood samples	H48 (48 hours after reperfusion)
Inflammatory markers rate	Inflammatory markers rate will be analyzed on blood samples	1 year follow-up after STEMI
Gut microbiota profiling	Gut microbiota will be assessed on feces samples. Metagenomic sequencing and 16S ribosomal ribonuleic acid (RNA) gene sequencing will be applied to investigate gut microbiota richness, diversity and composition.	Up to 8 days after STEMI
Gut microbiota profiling	Gut microbiota will be assessed on feces samples. Metagenomic sequencing and 16S ribosomal ribonuleic acid (RNA) gene sequencing will be applied to investigate gut microbiota richness, diversity and composition.	1 year follow-up after STEMI
Genitourinary microbiota profiling	Genitourinary microbiota will be assessed on urine samples. Metagenomic sequencing and 16S ribosomal ribonuleic acid (RNA) gene sequencing will be applied to investigate genitourinary microbiota richness, diversity and composition.	Up to 8 days after STEMI
Genitourinary microbiota profiling	Genitourinary microbiota will be assessed on feces samples. Metagenomic sequencing and 16S ribosomal ribonuleic acid (RNA) gene sequencing will be applied to investigate genitourinary microbiota richness, diversity and composition.	1 year follow-up after STEMI
EQ-5D-3L score (European Quality of Life 5 Dimensions 3 Level version)	Patients' quality of life will be evaluated by the EQ-5D-3L questionnaire, which ranges from 5 to 15, with a highest score meaning a worse outcome	Up to 8 days after STEMI
EQ-5D-3L score (European Quality of Life 5 Dimensions 3 Level version)	Patients' quality of life will be evaluated by the EQ-5D-3L questionnaire, which ranges from 5 to 15, with a highest score meaning a worse outcome	1 year follow-up after STEMI
Codex test	Patients' cognitive status will be evaluated by the Codex test	Up to 8 days after STEMI
Codex test	Patients' cognitive status will be evaluated by the Codex test	1 year follow-up after STEMI

Collaborators and Investigators

• Sponsor: Poitiers University Hospital
• Collaborators: Fédération Française de Cardiologie

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: December 19, 2023
• First Submitted That Met QC Criteria: February 19, 2024
• First Posted (Actual): February 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: cardiology
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: CARAMBOLE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No