Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT02967965 |
| Other study ID # |
CARIM |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 30, 2013 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
EZUS-LYON 1 |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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 elevation segment MI (STEMI) will be
recruited.
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
1. 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).
2. 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.
3. 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.
4. 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.
