External Counterpulsation (ECP) for the Promotion of Collateral Growth in Patients With Coronary Artery Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Collateral flow index (CFI)
Study Overview
Brief Summary
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.
Detailed Description
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 .
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age > 18 years old
- •1- to 3-vessel coronary artery disease (CAD)
- •Stable angina pectoris
- •At least 1 stenotic lesion suitable for PCI within the next 4 weeks
- •No Q-wave myocardial infarction in the area undergoing CFI measurement
- •Written informed consent to participate in the study
Exclusion Criteria
- •Patients admitted as emergencies
- •Acute myocardial infarction within the last 3 months
- •Unstable CAD
- •CAD treated best by CABG
- •Coronary stenotic lesion to be treated ad-hoc or within < 4 weeks
- •Severe valve disease
- •Pulmonary artery hypertension
- •Congestive heart failure
- •Atrial fibrillation
- •Thrombophlebitis and/or deep vein thrombosis
- •Occlusive peripheral artery disease
- •Abdominal aortic aneurysm
Outcomes
Primary Outcomes
Collateral flow index (CFI)
Time Frame: 21 days
Coronary collateral resistance (Rcoll)
Time Frame: 21 days
Secondary Outcomes
- Myocardial perfusion reserve(21 days)