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

This study is currently recruiting participants.
Verified March 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01113268
First received: April 28, 2010
Last updated: March 26, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
ST Elevation (STEMI) Myocardial Infarction of Other Sites
Other: Cohort

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
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)

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Identification of patients with LV remodeling from those without remodelling [ Time Frame: at day 4±2, at month 6 ] [ Designated as safety issue: No ]
    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 [ Time Frame: at month 6 ] [ Designated as safety issue: No ]
    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 [ Time Frame: years 3 to 7 ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 750
Study Start Date: September 2010
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 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.

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:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01113268

Locations
France
Pr Jean-Jacques MERCADIER Recruiting
Paris, France, 75018
Contact: Jean-Jacques MERCADIER, MD,PhD    33 1 40 25 84 02    jean-jacques.mercadier@bch.aphp.fr   
Principal Investigator: Gabriel STEG, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Study Director: Jean-Jacques MERCADIER, MD,PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01113268     History of Changes
Other Study ID Numbers: P081116, 2010-A00156-33
Study First Received: April 28, 2010
Last Updated: March 26, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Patient collection
Cardiac remodelling
Echography
Magnetic Resonance Imaging
Gene polymorphisms
Biomarkers

Additional relevant MeSH terms:
Disease Susceptibility
Heart Failure
Infarction
Myocardial Infarction
Genetic Predisposition to Disease
Disease Attributes
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Ischemia
Necrosis
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on April 21, 2014