Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2025-12-24 @ 3:16 PM
NCT ID:
NCT06269692
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18 years;
* Patients with a LVEF≤35% assessed at least after a 40 to 90 days period (depending on the presence of coronary revascularization) following an index myocardial infarction;
* Left ventricular systolic impairment as defined by LVEF≤35% by any current standard technique (echocardiogram, multiple gated acquisition scan, or MRI) within 2 months;
* Able and willing to comply with all pre-, post- and follow-up testing, and requirements;
* Use of maximum tolerated doses of ACE inhibitors (or Angiotensin II Receptor Blockers if intolerant of ACE) and Beta Blockers and MRA as per ESC guidelines;
* Person affiliated to or beneficiary of a social security plan
* Person informed about study organization and having signed the informed consent
Exclusion Criteria:
* History of cardiac arrest or sustained VT or VF unless within 48 hours of an acute myocardial infarction;
* Standard contraindications for cardiac LGE-MRI;
* Hypersensitivity to gadolinium-based contrast agent;
* Currently implanted permanent pacemaker and/or ICD;
* Patient refusal of ICD/ILR implantation;
* Currently implanted permanent pacemaker and/or ICD;
* Clinical indication for or Cardiac Resynchronization Therapy (CRT);
* Severe renal insufficiency defined by a glomerular filtration rate (GFR) \< 30 mL/min/1.73m²;
* Recent PTCA (within 30 days) or CABG (within 90 days);
* Baseline NYHA functional class IV;
* Contraindication for ICD implantation according to current guidelines;
* Woman of childbearing age without effective contraception;
* Person referred in articles L.1121-5, L. 1121-7 and L.1121-8 of the French Public Health Code.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06269692
Study Brief:
Protocol Section:
NCT06269692