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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00414297
• Other study ID #: 61/06
• Status: Completed
• Phase: N/A
• First received: December 20, 2006
• Last updated: October 25, 2010
• Start date: August 2006
• Est. completion date: June 2009

Study information

• Verified date: October 2010
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• ECP Therapy
application of ECP Therapy to CAD Patients

Locations

Country	Name	City	State
Switzerland	Bern University Hospital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collateral flow index (CFI)		21 days	No
Primary	Coronary collateral resistance (Rcoll)		21 days	No
Secondary	Myocardial perfusion reserve		21 days	No

External Links

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