Coronary Artery Disease Clinical Trial
Official title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Intramyocardial Injection of Autologous Bone-Marrow Cells in Patients With Severe, Chronic Ischemic Heart Disease Undergoing Coronary Bypass Surgery
This study was designed to test the hypothesis that direct injection of bone-marrow cells in the heart may increase the number of blood vessels, ameliorating the heart's performance, and relieving patients from symptoms like angina and/or shortness of breath.
Severe ischemic heart disease (IHD) remains a clinical challenge; many patients with IHD
have undergone myocardial revascularization procedures (either percutaneous or surgical) but
still remain symptomatic despite maximally tolerated medical therapy. Others are considered
non-optimal candidates for a complete myocardial revascularization procedure due to the
extension and diffuseness of the disease.
Cell therapy with autologous bone marrow-derived cells (BMC) is a novel therapeutic strategy
being tested for many cardiovascular diseases, including heart failure, acute myocardial
infarction, chronic ischemic heart disease.
The primary objective of this study is to assess the efficacy of intramyocardial injection
of autologous BMC on the myocardial perfusion and left ventricular function as an adjunctive
therapy (compared to placebo) in patients undergoing coronary artery bypass surgery (CABG).
The secondary objective of this study is to assess the effect of intramyocardial injection
of autologous BMC on functional class (angina/heart failure), functional capacity, global
and cardiovascular mortality, and quality of life in patients undergoing coronary artery
bypass surgery (CABG).
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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