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

Primary Purpose

ST Elevation (STEMI) Myocardial Infarction of Other Sites

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cohort
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for ST Elevation (STEMI) Myocardial Infarction of Other Sites focused on measuring Patient collection, Cardiac remodelling, Echography, Magnetic Resonance Imaging, Gene polymorphisms, Biomarkers

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pr Damien LOGEART

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1:cohort

Arm Description

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.

Outcomes

Primary Outcome Measures

Identification of patients with LV remodeling from those without remodelling
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.

Secondary Outcome Measures

Degree of LV remodelling
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.
Power of the mutations/ polymorphisms, biomarkers and other intermediate phenotypes identified in predicting cardiovascular events
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).

Full Information

First Posted
April 28, 2010
Last Updated
August 23, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT01113268
Brief Title
PREdisposition Genetical in Cardiac Insufficiency = Genetic Predisposition to Heart Failure
Acronym
PREGICA
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Study Start Date
September 30, 2010 (Actual)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
August 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST Elevation (STEMI) Myocardial Infarction of Other Sites
Keywords
Patient collection, Cardiac remodelling, Echography, Magnetic Resonance Imaging, Gene polymorphisms, Biomarkers

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
658 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1:cohort
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cohort
Intervention Description
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.
Primary Outcome Measure Information:
Title
Identification of patients with LV remodeling from those without remodelling
Description
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.
Time Frame
at day 4±2, at month 6
Secondary Outcome Measure Information:
Title
Degree of LV remodelling
Description
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.
Time Frame
at month 6
Title
Power of the mutations/ polymorphisms, biomarkers and other intermediate phenotypes identified in predicting cardiovascular events
Description
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).
Time Frame
years 3 to 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Damien LOGEART, MD,PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Director
Facility Information:
Facility Name
Pr Damien LOGEART
City
Paris
ZIP/Postal Code
75010
Country
France

12. IPD Sharing Statement

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PREdisposition Genetical in Cardiac Insufficiency = Genetic Predisposition to Heart Failure

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