Acute Myocardial Infarction Clinical Trial
Official title:
A Phase II, Multicenter, Adaptive-design Study to Assess the Safety and Efficacy of VM202RY Injected Via Percutaneous Transendocardial Route in Subjects With Acute Myocardial Infarction
The purpose of this study is to evaluate the safety and clinical efficacy of VM202RY injected
via transendocardial route using C-Cathez® catheter (Celyad, S.A., Belgium) in subjects with
AMI.
- Stage 1: Evaluation of safety and tolerability of VM202RY injection
- Stage 2: Evaluation of safety and efficacy of VM202RY injection
Ischemic heart disease, a condition in which narrowed or blocked coronary arteries lead to
ischemia in myocardium, is a group of disease that include: angina and myocardial infarction.
Acute myocardial infarction (AMI) predicts rapid progression of necrosis. AMI is a serious
health condition that it's mortality rate is about 30% and also more likely to have a higher
incidence of cardiac dysrhythmia or ventricular aneurysm.
Therapeutic angiogenesis is promising approach for the treatment of cardiovascular disease.
66 to 75% of coronary artery disease patients have insufficient coronary collaterals and 30%
of myocardial infarction patients display inadequate myocardial perfusion although there are
procedures like percutaneous coronary intervention or coronary artery bypass graft surgery.
In phase I study for ischemic heart disease, VM202RY appeared to have improved regional
myocardial perfusion and wall thickness of the diastolic and systolic phases in the injected
region. These results suggest that VM202RY improves the myocardial perfusion and inhibits
cardiac remodeling in ischemic heart disease patients.
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