Myocardial InfarctCARIMNCT02967965
CARdioprotection in Myocardial Infarction
An observational study of Myocardial Infarct, run by EZUS-LYON 1 at 2 sites in France.
Trial summary
CARIM is a prospective cohort of 2,000 patients with a first myocardial infarction and undergoing reperfusion therapy. Therefore, male and female patients older than 18 years and younger than 90 years with onset of chest pain of less than 12 hours who need a primary percutaneous coronary intervention (PCI) for a ST… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Myocardial Infarct
- What is being tested?
- Imagery
- How many people
- 2,000 participants
- Where
- 2 sitesFrance
- Study dates
- 30 Nov 2013to 31 Dec 2024
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: CARIM is a prospective cohort of 2,000 patients with a first myocardial infarction and undergoing reperfusion therapy. Therefore, male and female patients older than 18 years and younger than 90 years with onset of chest pain of less than 12 hours who need a primary percutaneous coronary intervention (PCI) for a ST elevation segment MI (STEMI) will be recruited.
Who may be able to join
- Any patient hospitalized in the cardiology department of the participating centers
- Who have signed the Informed Consent Form.
- Patient having health insurance.
- Requiring PCI for reperfusion.
- With a diagnosis of a first MI.
- With ST segment elevation and/or Q wave at admission.
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- With troponin elevation.
- Seen within the first 12 hours after symptom onset.
- Aged between 18 and 90 years.
Who cannot join
- Refusal of the patient.
- In case of poor echogenicity, the participation of the patient will be stopped.
- Patient with diagnosis of previous MI, or hypertrophic or dilated cardiomyopathy, or significant valvular heart disease, or chronic atrial fibrillation, or pace maker or any permanent implanted device susceptible to interfere with LV remodeling.
- Patient with preexisting heart failure.
- Patient with any previous cardiac surgery.
- Patient with previous chemotherapy susceptible to induce LV remodeling (anthracyclines).
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- Patient with an associated short-time life-threatening disease.
- Pregnant or breast-feeding patient.
- Contra-indication to MRI (claustrophobia, pacemaker or any other metallic implants, creatinin clearance < 30mL/min/1.73m2 MDRD).
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Mondor
Créteil, Rhône, 94010
CHRU de Tours
Tours, Indre Et Loire, 37044
About this study
Official title: CARIM Cohort (CARdioprotection in Myocardial Infarction)
CARIM is a prospective cohort of 2,000 patients with a first myocardial infarction and undergoing reperfusion therapy. Therefore, male and female patients older than 18 years and younger than 90 years with onset of chest pain of less than 12 hours who need a primary percutaneous coronary intervention (PCI) for a ST elevation segment MI (STEMI) will be recruited.
Read the detailed description
In the setting of research in ischemic cardiomyopathy, the CARIM cohort aims to meet the expectation and strategy of Aviesan (Alliance nationale pour les sciences de la VIE et de la SANté) since it will address the underlying pathophysiology of the determinants of MI injury and its impact on follow-up, in addition with the potential confounding clinical and biological factors. Therefore, CARIM cohort will offer a great opportunity of describing the interactions between myocardial infarction and surrounding environment (clinical, social and professional). This cohort will use complementary state of the art approaches (cardiac imaging including Cardiovascular Magnetic Resonance and echocardiography, biomarkers, proteomic, genetic and pharmacogenetics) with strong interactions between the different partners. Therefore CARIM cohort should help to obtain a modeling of the determinants of the MI size.
The investigators expect that CARIM cohort will provide new imaging or biological markers that may bring early information regarding the severity of lethal reperfusion injury.
By optimizing the knowledge on infarct injury in addition with a 5-year clinical and echographic follow-up, this cohort will better stratify the prognosis after MI and will therefore give new insights in identifying patients at higher risk of left ventricular remodeling and subsequent heart failure. It will therefore help and emphasize prevention messages and patients' education. The aim is to translate this information directly into patient care by using the science generated by this project to develop new management guidelines and novel clinical tools (confounder-annotated database, imaging and biological biomarkers). This cohort may have additional impact in patient care by adapting the treatment to patient-related confounders (age, diabetes...), genetic polymorphisms and thus personalizing health care to individuals.
3.2 MAIN OBJECTIVE
The investigators main objective is to create a prospective cohort of 2,000 patients (CARIM cohort) with a first myocardial infarction and undergoing reperfusion therapy in order to evaluate the impact of patient-related confounders on myocardial infarct size and LRI in order to further design a modeling of myocardial infarct size.
For this purpose, CARIM cohort will be associated with the creation of a non-invasive cardiac imaging data-bank (MRI and echocardiography) in addition with a large bio-bank relying on existing biological certified platforms (i.e. BRC network).
This cohort will provide a population of first acute MI, optimally characterized in terms of comprehensive clinical and angiography phenotype, specifically characterized by CMR in terms of infarct size and LRI and by echocardiography in terms of myocardial regional function and left ventricular remodeling.
3.3 SECONDARY OBJECTIVES
- Evaluate the specific impact of myocardial infarct injury on myocardial regional function and left ventricular remodeling (defined by an increase in LV end-diastolic volume > 20% between week 1 and month 12 post-MI by echocardiography).
- Evaluate the power of the myocardial infarct injury in predicting cardiovascular events (rehospitalizations, reinfarction, occurrence of HF, transplantation, arrhythmias, death) in a 5-year patient follow-up.
- Test the value of established or newly identified plasma/serum biomarkers to identify LRI and to predict post-MI LV remodeling and progression towards CHF during a 5 year follow-up.
- This cohort aims ultimately at defining the profile of the MI patient population to be used for future trials implementing new protective interventions targeting LRI.
- Conditions
- Myocardial Infarct
- Being tested
- Imagery
- Keywords
- clinical confounders, myocardial infarction size, determinants of myocardial infarct injury
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImageryOther
Also called MRI
MRI at year 3
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Clinical Evaluation, Coronarography, Imagery by MRI, Echocardiography and Biological samples will be collected for each patient. Receives: Other: Imagery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determinants of myocardial infarct injury
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study start30 Nov 2013
- Primary completion31 Dec 2022
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EZUS-LYON 1
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Genevieve DERUMEAUX, Professor, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02967965
- Sponsor's protocol ID
- CARIM
- Acronym
- CARIM
- Status last verified
- Feb 2024
- First submitted
- 10 Nov 2016
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CARIM Cohort (CARdioprotection in Myocardial Infarction)
- ClinicalTrials.gov ID
- NCT02967965
- Acronym / sponsor ID
- CARIM / CARIM
- Conditions
- Myocardial Infarct
- Keywords
- clinical confounders, myocardial infarction size, determinants of myocardial infarct injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- EZUS-LYON 1University, hospital or other
- Study start
- 30 Nov 2013 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Nov 2016 (estimated)
- 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.
CARIM is a prospective cohort of 2,000 patients with a first myocardial infarction and undergoing reperfusion therapy. Therefore, male and female patients older than 18 years and younger than 90 years with onset of chest pain of less than 12 hours who need a primary percutaneous coronary intervention (PCI) for a ST elevation segment MI (STEMI) will be recruited.
Detailed description
In the setting of research in ischemic cardiomyopathy, the CARIM cohort aims to meet the expectation and strategy of Aviesan (Alliance nationale pour les sciences de la VIE et de la SANté) since it will address the underlying pathophysiology of the determinants of MI injury and its impact on follow-up, in addition with the potential confounding clinical and biological factors. Therefore, CARIM cohort will offer a great opportunity of describing the interactions between myocardial infarction and surrounding environment (clinical, social and professional). This cohort will use complementary state of the art approaches (cardiac imaging including Cardiovascular Magnetic Resonance and echocardiography, biomarkers, proteomic, genetic and pharmacogenetics) with strong interactions between the different partners. Therefore CARIM cohort should help to obtain a modeling of the determinants of the MI size.
The investigators expect that CARIM cohort will provide new imaging or biological markers that may bring early information regarding the severity of lethal reperfusion injury.
By optimizing the knowledge on infarct injury in addition with a 5-year clinical and echographic follow-up, this cohort will better stratify the prognosis after MI and will therefore give new insights in identifying patients at higher risk of left ventricular remodeling and subsequent heart failure. It will therefore help and emphasize prevention messages and patients' education. The aim is to translate this information directly into patient care by using the science generated by this project to develop new management guidelines and novel clinical tools (confounder-annotated database, imaging and biological biomarkers). This cohort may have additional impact in patient care by adapting the treatment to patient-related confounders (age, diabetes...), genetic polymorphisms and thus personalizing health care to individuals.
3.2 MAIN OBJECTIVE
The investigators main objective is to create a prospective cohort of 2,000 patients (CARIM cohort) with a first myocardial infarction and undergoing reperfusion therapy in order to evaluate the impact of patient-related confounders on myocardial infarct size and LRI in order to further design a modeling of myocardial infarct size.
For this purpose, CARIM cohort will be associated with the creation of a non-invasive cardiac imaging data-bank (MRI and echocardiography) in addition with a large bio-bank relying on existing biological certified platforms (i.e. BRC network).
This cohort will provide a population of first acute MI, optimally characterized in terms of comprehensive clinical and angiography phenotype, specifically characterized by CMR in terms of infarct size and LRI and by echocardiography in terms of myocardial regional function and left ventricular remodeling.
3.3 SECONDARY OBJECTIVES
- Evaluate the specific impact of myocardial infarct injury on myocardial regional function and left ventricular remodeling (defined by an increase in LV end-diastolic volume > 20% between week 1 and month 12 post-MI by echocardiography).
- Evaluate the power of the myocardial infarct injury in predicting cardiovascular events (rehospitalizations, reinfarction, occurrence of HF, transplantation, arrhythmias, death) in a 5-year patient follow-up.
- Test the value of established or newly identified plasma/serum biomarkers to identify LRI and to predict post-MI LV remodeling and progression towards CHF during a 5 year follow-up.
- This cohort aims ultimately at defining the profile of the MI patient population to be used for future trials implementing new protective interventions targeting LRI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | Other: ImageryClinical Evaluation, Coronarography, Imagery by MRI, Echocardiography and Biological samples will be collected for each patient. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CARIM is a prospective cohort of 2,000 patients with a first myocardial infarction and undergoing reperfusion therapy. Therefore, male and female patients older than 18 years and younger than 90 years with onset of chest pain of less than 12 hours who need a primary percutaneous coronary intervention (PCI) for a ST elevation segment MI (STEMI) will be recruited.
Key inclusion criteria (9 listed)
- Any patient hospitalized in the cardiology department of the participating centers
- Who have signed the Informed Consent Form.
- Patient having health insurance.
- Requiring PCI for reperfusion.
- With a diagnosis of a first MI.
Key exclusion criteria (9 listed)
- Refusal of the patient.
- In case of poor echogenicity, the participation of the patient will be stopped.
- Patient with diagnosis of previous MI, or hypertrophic or dilated cardiomyopathy, or significant valvular heart disease, or chronic atrial fibrillation, or pace maker or any permanent implanted device susceptible to interfere with LV remodeling.
- Patient with preexisting heart failure.
- Patient with any previous cardiac surgery.
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 |
|---|---|---|
| ImageryAlso: MRIMRI at year 3 | Other | Cohort |
Primary outcome
Determinants of myocardial infarct injury
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Genevieve DERUMEAUX, Professor principal investigator
APHP
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarct, run by EZUS-LYON 1 at 2 sites 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 9 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
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?
Determinants of myocardial infarct injury (time frame: 5 years). 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 29 Feb 2024.