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
Patients with advanced coronary artery disease usually undergo incomplete myocardial
revascularization due to the extension and diffuseness of the disease, with very poor distal
arterial beds unsuitable for direct revascularization.
This study was designed to test the hypothesis that direct, intramyocardial injection of
autologous bone marrow cells may further improve myocardial perfusion in patients undergoing
incomplete bypass surgery.
All eligible patients will undergo coronary artery bypass grafting (CABG) and, in previously
identified areas of viable, ischemic myocardium unsuitable for direct revascularization, be
randomized to either placebo (saline) or intramyocardial injection of bone marrow-derived
cells (BMC) during surgery.
During follow-up, myocardial perfusion assessment will be performed to determine the
improvement in treated areas compared to non-treated segments.
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