PREdisposition Genetical in Cardiac Insufficiency = Genetic Predisposition to Heart Failure (PREGICA)

August 23, 2023 updated by: Assistance Publique - Hôpitaux de Paris

Role of Candidate Genes/Signalling Pathways in the Progression Towards Heart Failure: Study in a Cohort of Patients With a First Myocardial Infarction (PREGICA Patient Collection : Genetic Predisposition to Heart Failure)

Our main goal is to create a prospective cohort of 1500 patients with a first large myocardial infarction allowing us, in a second step, to identify susceptibility genes for the progression of patients towards chronic heart failure using a candidate gene/candidate pathway approach. Our main hypothesis is that there is, for a given initial biomechanical stress (duration of the ischemic episode, size of the infarcted area, etc.), a variation in the individual susceptibility to develop left ventricular remodelling and to progress towards heart failure, and that this variation is linked to genetic variants between individuals.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The research program comprises 4 phases: a selection phase at D0-D1, a pre-inclusion and an inclusion phase at D4±2, a visit at M6, and a 5 year follow up phase.

Visit at Day 0 - Day 1:

  • The first 12-lead ECG, to be included in the observation book, is performed.
  • The first blood sample is taken.

Visit at Day 4±2:

  • The first transthoracic echocardiography is performed in all patients selected.
  • In the presence of at least 3 akinetic LV segments at the transthoracic echocardiography, the patient is included.
  • Demographic data, medical and surgical anteriority, detailed circumstances of occurrence of the MI and any other relevant information is obtained during an interview.
  • The second 12-lead ECG is performed.
  • The second blood sample is taken.
  • The first MRI is performed (optional)

Visit at 6 months:

  • The second transthoracic echocardiography is performed.
  • The third 12-lead ECG is performed.
  • The third blood sample is taken.
  • A 24-hour Holter-ECG monitoring is performed (optional)
  • The second MRI is performed (optional)

Five year follow up (phone contact until 7 years after inclusion):

Each patient included at day 4±2 will be contacted by phone 1, 2, 3, 4 and 5 years post-MI to obtain information regarding cardiovascular events and hospitalizations. If the patient cannot be contacted directly, we will try to contact a member of his/her family or his/her family physician.

Study Type

Interventional

Enrollment (Actual)

658

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75010
        • Pr Damien LOGEART

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

*Selection criteria

Any patient hospitalised in the CCU of the participating centers:

  • with a diagnosis of a first MI
  • with ST segment elevation and/or Q wave at admission
  • with troponin elevation
  • seen within the first 24 hours after symptom onset
  • aged between 18 and 80 years is selected.

  • consent emergency clause: His/her informed consent is obtained and he/she signs the consent form or However, if a member of the patients' family is present, his/her consent must be obtained or no consent

    *Inclusion

  • The first transthoracic echocardiography is performed at day 4±2 in all patients selected.
  • In the presence of at least 3 akinetic LV segments at the transthoracic echocardiography, the patient is included.

Exclusion Criteria:

*Non-selection criteria:

  • Informed consent not obtained.
  • Patients with diagnosis of previous MI, hypertrophic or dilated cardiomyopathy, significant valvular heart disease, chronic atrial fibrillation, or pace maker or any permanently implanted device susceptible to interfere with LV remodelling.
  • Patients with preexisting heart failure.
  • Patients having undergone previous cardiac surgery.
  • Patients having received chemotherapy susceptible to induce LV remodeling (anthracyclines).
  • Patients with an associated short-time life-threatening disease.
  • Patients with poor echogenicity.
  • Patients without health insurance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1:cohort
Our main goal is to create a prospective cohort of 1500 patients with a first large myocardial infarction allowing us, in a second step, to identify susceptibility genes for the progression of patients towards chronic heart failure using a candidate gene/candidate pathway approach.
Other: Cohort
Our main goal is to create a prospective cohort of 1500 patients with a first large myocardial infarction allowing us, in a second step, to identify susceptibility genes for the progression of patients towards chronic heart failure using a candidate gene/candidate pathway approach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of patients with LV remodeling from those without remodelling
Time Frame: at day 4±2, at month 6
Our main judgement criterion allowing to distinguish patients with LV remodeling from those without remodelling will be an increase in LV end-diastolic volume > 20% between day 4±2 and month 6 post-MI.
at day 4±2, at month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of LV remodelling
Time Frame: at month 6
To evaluate the degree of LV remodelling (including ventricular arrhythmias) 6 months after a first ST-segment elevation myocardial infarction (STEMI) or Q-wave MI at the era of early revascularization.
at month 6
Power of the mutations/ polymorphisms, biomarkers and other intermediate phenotypes identified in predicting cardiovascular events
Time Frame: years 3 to 7
To evaluate the power of the mutations/ polymorphisms, biomarkers and other intermediate phenotypes identified in predicting cardiovascular events (rehospitalizations, reinfarction, occurrence of HF, transplantation, arrhythmias, death) in a 5-year patient follow-up (years 3 to 7).
years 3 to 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Study Director: Damien LOGEART, MD,PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2010

Primary Completion (Actual)

September 30, 2017

Study Completion (Actual)

August 23, 2023

Study Registration Dates

First Submitted

April 28, 2010

First Submitted That Met QC Criteria

April 28, 2010

First Posted (Estimated)

April 29, 2010

Study Record Updates

Last Update Posted (Actual)

August 25, 2023

Last Update Submitted That Met QC Criteria

August 23, 2023

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P081116
  • 2010-A00156-33 (Other Identifier: IDRCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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