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

Sponsor

University Hospital Inselspital, Berne (Other)

Overall Status

Completed

CT.gov ID

NCT00414297

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Device: ECP Therapy	N/A

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

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2006

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 ECP active ECP Therapy	Device: ECP Therapy application of ECP Therapy to CAD Patients
Placebo Comparator: 2 Sham ECP Treatment	Device: ECP Therapy application of ECP Therapy to CAD Patients

Arm

Intervention/Treatment

Active Comparator: 1 ECP

active ECP Therapy

Device: ECP Therapy

application of ECP Therapy to CAD Patients

Placebo Comparator: 2

Sham ECP Treatment

Device: ECP Therapy

application of ECP Therapy to CAD Patients

Outcome Measures

Primary Outcome Measures

Collateral flow index (CFI) [21 days]
Coronary collateral resistance (Rcoll) [21 days]

Secondary Outcome Measures

Myocardial perfusion reserve [21 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bern University Hospital	Bern		Switzerland	3010

Sponsors and Collaborators

University Hospital Inselspital, Berne

Investigators

Study Chair: Christian Seiler, MD, Prof., University of Bern
Principal Investigator: Steffen Gloekler, MD, University of Bern

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00414297

Other Study ID Numbers:

61/06

First Posted:

Dec 21, 2006

Last Update Posted:

Oct 26, 2010

Last Verified:

Oct 1, 2010

Keywords provided by , ,

Additional relevant MeSH terms:

Coronary Artery Disease

Myocardial Ischemia

Coronary Disease

Study Results

No Results Posted as of Oct 26, 2010