Coronary Artery Disease Clinical Trial
Official title:
Coronary Artery Bypass Graft Surgery Combined Pedicled Omentum Wrapped Autologous Atrial Tissue Patch Cardiomyoplasty for Patients With Ischemic Cardiomyopathy: a Prospective Randomized Controlled Clinical Trial
The purpose of this study is in a phase I/II safety and efficacy study to evaluate the clinical effect of coronary artery bypass graft (CABG) combined pedicled omentum wrapped autologous atrial tissue patch cardiomyoplasty for patients with ischemic cardiomyopathy.
This is a phase I/II, randomized controlled trial to evaluate the use of CABG combined
pedicled omentum wrapped autologous atrial tissue patch cardiomyoplasty for patients with
ischemic cardiomyopathy. The study hypothesis is that the combined surgical technique to
perform pedicled omentum wrapped autologous atrial tissue patch cardiomyoplasty as adjunct
to CABG, is safe to patients with severe ischemic heart failure and can improve regional
myocardial perfusion contractility, which resulting in improved systolic and diastolic left
ventricular function.
The primary object of this study will be to evaluate the safety and efficacy of this novel
combined surgical technique. The efficacy will be assessed changes in left ventricular
ejection fraction by MRI. The secondary endpoint of the study is to assess the effects of
this novel combined surgical technique on cardiac contractile function and functional
outcome. The effects will be assessed on the basis of clinical status and imaging rests in 6
month follow-up after enrollment. A maximum of 60 patients between 20 and 70 years will be
enrolled in the study. These participants will be randomized to receive CABG, pedicled
omentum graft combined CABG, or pedicled omentum graft autologous atrial tissue patch
cardiomyoplasty combined CABG. The objective evaluations will be performed at baseline and
during 6 months follow-up.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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