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:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT02735993
Eligibility Criteria:
Inclusion Criteria:
* Males or females \> 20 and \< 80 years of age
* Significant multi-vessel coronary artery disease not amenable to percutaneous or surgical revascularization OR idiopathic dilated cardiomyopathy
* Symptoms of heart failure (e.g. NYHA Stages of Heart Failure Class II or III)
* On maximal medical therapy for heart failure and if present, anginal symptoms
* Hemodynamic stability (SBP ≥ 90 mm/Hg, HR \<110 beats/min)
* Ejection fraction ≤ 45%
* Left ventricular wall thickness \> 5 mm at the target site(s) for cell injection, confirmed by Contrast Echo within 4 weeks prior to enrollment, and free of thrombus
Exclusion Criteria:
* Vascular anatomy and/or peripheral artery disease that prevents or impedes cardiac catheterization
* Aortic or mitral valve disease where valve replacement is indicated
* Presence of mechanical aortic or mitral valves
* Presence of aortic dissection
* Planned staged treatment of CAD or other therapeutic intervention on the heart within the subsequent 3 months
* TIA or stroke within 30 days prior to the procedure
* ICD placement or ablation therapy within 30 days prior to the procedure
* Acute coronary syndrome (ACS) or a myocardial infarction in the 30 days prior to the procedure
* Revascularization within 30 days prior to intramyocardial injection of ADRCs
* Pregnant or lactating status. Pregnancy as determined by a positive pregnancy test at screening or baseline.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
80 Years
Study:
NCT02735993
Study Brief:
Protocol Section:
NCT02735993