PREdisposition Genetical in Cardiac Insufficiency = Genetic Predisposition to Heart Failure (NCT01113268) | Clinical Trial Compass
TerminatedNot Applicable
PREdisposition Genetical in Cardiac Insufficiency = Genetic Predisposition to Heart Failure
France658 participantsStarted 2010-09-30
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Identification of patients with LV remodeling from those without remodelling