NCT02967965

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2013

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2013

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

November 10, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 18, 2016

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 29, 2024

Status Verified

February 1, 2024

Enrollment Period

9.1 years

First QC Date

November 10, 2016

Last Update Submit

February 28, 2024

Conditions

Myocardial Infarct

Keywords

clinical confoundersmyocardial infarction sizedeterminants of myocardial infarct injury

Outcome Measures

Primary Outcomes (1)

  • Determinants of myocardial infarct injury

    5 years

Study Arms (1)

Cohort

Clinical Evaluation, Coronarography, Imagery by MRI, Echocardiography and Biological samples will be collected for each patient.

Other: Imagery

Interventions

ImageryOTHER

MRI at year 3

Also known as: MRI
Cohort

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.
  • With troponin elevation.
  • Seen within the first 12 hours after symptom onset.
  • Aged between 18 and 90 years.

You may not qualify if:

  • 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).
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHRU de Tours

Tours, Indre Et Loire, 37044, France

Location

Hôpital Mondor

Créteil, Rhône, 94010, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

J2-4: 63 mL (3 dry tubes ; 2 citrate tubes and 4 tubes with EDTA, with 2 for DNA isolation) M6: 28 mL (2 dry tube, 1 citrate tube and 1 tube with EDTA) M12: 21 mL (1 dry tube, 1 citrate tube and 1 tube with EDTA) Optional: In centers adequately equipped for management of blood samples in the catheterization laboratory, blood samples will be also taken at JO, before and 4 hours after reperfusion (14 ml each: 1 dry tube and 1 tube with EDTA) after obtention of the agreement of the patient to be included in the cohort CARIM.

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Genevieve DERUMEAUX, Professor

    APHP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2016

First Posted

November 18, 2016

Study Start

November 30, 2013

Primary Completion

December 31, 2022

Study Completion

December 31, 2024

Last Updated

February 29, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)