Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2025-12-26 @ 11:07 PM
Study NCT ID:
NCT01113268
Status:
TERMINATED
Last Update Posted:
2023-08-25
First Post:
2010-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PREdisposition Genetical in Cardiac Insufficiency = Genetic Predisposition to Heart Failure
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
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)
Status:
TERMINATED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREGICA
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2010-A00156-33 | OTHER | IDRCB | View |