PREdisposition Genetical in Cardiac Insufficiency = Genetic Predisposition to Heart Failure

NCT01113268 | Terminated

• 2 other identifiers: P0811162010-A00156-33
• Study Type: interventional
• Target: 658
• Locations: 1 country
• Sites: 1

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.

Conditions

ST Elevation (STEMI) Myocardial Infarction of Other Sites

Keywords

Patient collection; Cardiac remodelling; Echography; Magnetic Resonance Imaging; Gene polymorphisms; Biomarkers

Outcome Measures

Primary Outcomes (1)

• 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.

  at day 4±2, at month 6

Secondary Outcomes (2)

• Degree of LV remodelling

  at month 6

• Power of the mutations/ polymorphisms, biomarkers and other intermediate phenotypes identified in predicting cardiovascular events

  years 3 to 7

Study Arms (1)

1:cohort

OTHER

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

Interventions

Cohort OTHER

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.

1:cohort

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \*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
• 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.

You may not qualify if:

• \*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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Pr Damien LOGEART

Paris, 75010, France

Location

Related Publications (1)

• Masurkar N, Bouvet M, Logeart D, Jouve C, Drame F, Claude O, Roux M, Delacroix C, Bergerot D, Mercadier JJ, Sirol M, Gellen B, Livrozet M, Fayol A, Robidel E, Tregouet DA, Marazzi G, Sassoon D, Valente M, Hulot JS. Novel Cardiokine GDF3 Predicts Adverse Fibrotic Remodeling After Myocardial Infarction. Circulation. 2023 Feb 7;147(6):498-511. doi: 10.1161/CIRCULATIONAHA.121.056272. Epub 2022 Dec 9.

  PMID: 36484260 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Cohort Studies

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Damien LOGEART, MD,PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2010
• First Posted: April 29, 2010
• Study Start: September 30, 2010
• Primary Completion: September 30, 2017
• Study Completion: August 23, 2023
• Last Updated: August 25, 2023

Record last verified: 2022-06

Locations

FR (1)