Coronary Artery Disease Clinical Trial
Official title:
External Counterpulsation (ECP) for the Promotion of Collateral Growth in Patients With Coronary Artery Disease
The purpose of this study in humans with stable coronary artery disease (CAD) treatable by percutaneous coronary intervention (PCI) is to evaluate the efficacy of External Counterpulsation (ECP) with regard to the promotion of coronary collateral growth.
Alternative strategies for the promotion of coronary collaterals (arteriogenesis) are a
promising therapeutic alternative for at least 20% of all Patients with Coronary Artery
Disease (CAD). Beside growth factors, physical exercise has been shown to improve coronary
collateral function. Extracorporal Counterpulsation (ECP) mimics physical exercise in a
standardized way. Before and after ECP treatment, a quantitative invasive assessment of
absolute collateral flow (by calculating the CFI, i.e. Collateral Flow Index) and myocardial
perfusion is performed (with calculation of the CPI, i.e. Collateral Perfusion Index and
MPR, i.e. Myocardial Perfusion Reserve).
The study setting is single-blinded, sham-controlled and proceptive .
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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