Left Ventricular Dysfunction Clinical Trial
Official title:
A Prospective,Randomized, Placebo-Controlled Study of Intramyocardial Injection of Autologous Bone-Marrow Mononuclear Cells in Patients With Severe, Chronic Ischemic Heart Disease Undergoing Coronary Bypass Surgery
This prospective, randomized, placebo-controlled study was designed to assess the safety, feasibility and efficacy of intramyocardial injection of autologous bone marrow mononuclear cells in patients with severe, chronic ischemic disease scheduled to coronary artery bypass surgery.
Severe ischemic heart disease remains a clinical challenge; many patients have undergone
surgical myocardial revascularization procedures, but still remain symptomatic despite
optimal medical therapy. Cell therapy with autologous bone marrow-derived cells (BMC) is a
novel therapeutic strategy being tested for surgical treatment in patients with severe,
chronic ischemic heart disease.
This research study is being performed to find out more information about the safety,
feasibility, and efficacy of direct 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 heart function
evaluations will be performed by electrocardiogram, echocardiogram, and cMRI at baseline and
during 6 months follow-up.
The secondary objective of this study is to assess the effect of intramyocardial injection
of autologous BMC on functional class (angina/heart failure), global and cardiovascular
mortality, and major adverse cardiac events after undergoing coronary artery bypass surgery.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
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