Myocardial InfarctionCARAMBOLENCT06278519
CARdiAc Mri and BiOLogical samplEs at the Acute Phase of a Myocardial Infarction (CARAMBOLE)
A study testing Blood, urinary and feces collection, Cardiac MRI and Quality of life and cognitive status questionnaire in people with Myocardial Infarction, run by Poitiers University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Blood, urinary and feces collection, Cardiac MRI and Quality of life and cognitive status questionnaire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2024to 25 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Myocardial Infarction
- Being tested
- Blood, urinary and feces collection, Cardiac MRI, Quality of life and cognitive status questionnaire
- Keywords
- cardiology
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood, urinary and feces collectionBiological
Blood, urinary and feces collection, at inclusion during acute phase of STEMI, and one year after inclusion visit.
Cardiac MRIDevice
Cardiac MRI at the acute phase of STEMI (Day 5 +/- 3) and at 1-year follow-up
Quality of life and cognitive status questionnaireOther
Quality of life and cognitive status questionnaire at the acute phase of STEMI and at 1-year follow-up
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Blood, urinary and feces collection; Device: Cardiac MRI; Other: Quality of life and cognitive status questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 1 year after STEMI
Secondary outcomes (20)
Infarct size
Infarct size will be measured on Cardiac MRI
Measured: Up to 8 days after STEMI
Infarct size
Infarct size will be measured on Cardiac MRI
Measured: 1 year follow-up after STEMI
No-reflow size
No-reflow size will be measured on Cardiac MRI
Measured: Up to 8 days after STEMI
No-reflow size
No-reflow size will be measured on Cardiac MRI
Measured: 1 year follow-up after STEMI
Cardiac enzymes rate
Cardiac enzymes rate will be analyzed on blood samples
Measured: H0 (admission in Intensive Cardiac Care Unit)
Cardiac enzymes rate
Cardiac enzymes rate will be analyzed on blood samples
Measured: H24 (24 hours after reperfusion)
Cardiac enzymes rate
Cardiac enzymes rate will be analyzed on blood samples
Measured: H48 (48 hours after reperfusion)
Cardiac enzymes rate
Cardiac enzymes rate will be analyzed on blood samples
Measured: 1 year follow-up after STEMI
Inflammatory markers rate
Inflammatory markers rate will be analyzed on blood samples
Measured: H0 (admission in Intensive Cardiac Care Unit)
Inflammatory markers rate
Inflammatory markers rate will be analyzed on blood samples
Measured: H24 (24 hours after reperfusion)
Inflammatory markers rate
Inflammatory markers rate will be analyzed on blood samples
Measured: H48 (48 hours after reperfusion)
Inflammatory markers rate
Inflammatory markers rate will be analyzed on blood samples
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 1 year follow-up after STEMI
Codex test
Patients' cognitive status will be evaluated by the Codex test
Measured: Up to 8 days after STEMI
Codex test
Patients' cognitive status will be evaluated by the Codex test
Measured: 1 year follow-up after STEMI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start1 Mar 2024
- Primary completion25 Jul 2026
- Study completion25 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fédération Française de Cardiologie
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278519
- Sponsor's protocol ID
- CARAMBOLE
- Acronym
- CARAMBOLE
- Status last verified
- Oct 2026
- First submitted
- 19 Dec 2023
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac MRI and Biological Samples at the Acute Phase of a Myocardial Infarction
- ClinicalTrials.gov ID
- NCT06278519
- Acronym / sponsor ID
- CARAMBOLE / CARAMBOLE
- Conditions
- Myocardial Infarction
- Keywords
- cardiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Collaborators
- Fédération Française de Cardiologie
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 25 Jul 2026 (actual)
- Study completion
- 25 Jul 2026 (actual)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood and urinary collection, cardiac MRI | Experimental | Biological: Blood, urinary and feces collection, Device: Cardiac MRI, Other: Quality of life and cognitive status questionnaireBlood and urinary collection, cardiac MRI at inclusion during acute phase of STEMI, and one year after inclusion visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood, urinary and feces collectionBlood, urinary and feces collection, at inclusion during acute phase of STEMI, and one year after inclusion visit. | Biological | Blood and urinary collection, cardiac MRI |
| Cardiac MRICardiac MRI at the acute phase of STEMI (Day 5 +/- 3) and at 1-year follow-up | Device | Blood and urinary collection, cardiac MRI |
| Quality of life and cognitive status questionnaireQuality of life and cognitive status questionnaire at the acute phase of STEMI and at 1-year follow-up | Other | Blood and urinary collection, cardiac MRI |
Primary outcome
Major Adverse cardiac Events (MACE)
Time frame: 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
20 secondary outcomes
Infarct size
Time frame: Up to 8 days after STEMI
Infarct size
Time frame: 1 year follow-up after STEMI
No-reflow size
Time frame: Up to 8 days after STEMI
No-reflow size
Time frame: 1 year follow-up after STEMI
Cardiac enzymes rate
Time frame: H0 (admission in Intensive Cardiac Care Unit)
Cardiac enzymes rate
Time frame: H24 (24 hours after reperfusion)
Cardiac enzymes rate
Time frame: H48 (48 hours after reperfusion)
Cardiac enzymes rate
Time frame: 1 year follow-up after STEMI
Inflammatory markers rate
Time frame: H0 (admission in Intensive Cardiac Care Unit)
Inflammatory markers rate
Time frame: H24 (24 hours after reperfusion)
Inflammatory markers rate
Time frame: H48 (48 hours after reperfusion)
Inflammatory markers rate
Time frame: 1 year follow-up after STEMI
Gut microbiota profiling
Time frame: Up to 8 days after STEMI
Gut microbiota profiling
Time frame: 1 year follow-up after STEMI
Genitourinary microbiota profiling
Time frame: Up to 8 days after STEMI
Genitourinary microbiota profiling
Time frame: 1 year follow-up after STEMI
EQ-5D-3L score (European Quality of Life 5 Dimensions 3 Level version)
Time frame: Up to 8 days after STEMI
EQ-5D-3L score (European Quality of Life 5 Dimensions 3 Level version)
Time frame: 1 year follow-up after STEMI
Codex test
Time frame: Up to 8 days after STEMI
Codex test
Time frame: 1 year follow-up after STEMI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood, urinary and feces collection, Cardiac MRI and Quality of life and cognitive status questionnaire in people with Myocardial Infarction, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse cardiac Events (MACE) (time frame: Up to 1 year after STEMI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.