ST Elevation (STEMI) Myocardial Infarction of Other Sites Clinical Trial
— PREGICAOfficial 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)
| Verified date | June 2022 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 658 |
| Est. completion date | August 23, 2023 |
| Est. primary completion date | September 30, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| France | Pr Damien LOGEART | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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. | at month 6 | |
| Secondary | 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). | years 3 to 7 |