External Counterpulsation (ECP) for the Promotion of Collateral Growth in Patients With Coronary Artery Disease

Study Overview
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Brief Summary
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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
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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 .

Official Title
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External Counterpulsation (ECP) for the Promotion of Collateral Growth in Patients With Coronary Artery Disease

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: ECP Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 ECP<br>active ECP Therapy | Device: ECP Therapy<br>* application of ECP Therapy to CAD Patients<br>|
| Placebo Comparator: 2<br>Sham ECP Treatment | Device: ECP Therapy<br>* application of ECP Therapy to CAD Patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collateral flow index (CFI) |  | 21 days | 
| Coronary collateral resistance (Rcoll) |  | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial perfusion reserve |  | 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CAD, ECP, CFI, CPI, MPR