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

This study has been completed.
Information provided by:
University Hospital Inselspital, Berne Identifier:
First received: December 20, 2006
Last updated: October 25, 2010
Last verified: October 2010

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 Intervention
Coronary Artery Disease
Device: ECP Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: External Counterpulsation (ECP) for the Promotion of Collateral Growth in Patients With Coronary Artery Disease

Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Collateral flow index (CFI) [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • Coronary collateral resistance (Rcoll) [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Myocardial perfusion reserve [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: August 2006
Study Completion Date: June 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 .


Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00414297

Bern University Hospital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Study Chair: Christian Seiler, MD, Prof. University of Bern
Principal Investigator: Steffen Gloekler, MD University of Bern
  More Information

No publications provided by University Hospital Inselspital, Berne

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: BernUniversity Hospital, Cardiology Identifier: NCT00414297     History of Changes
Other Study ID Numbers: 61/06
Study First Received: December 20, 2006
Last Updated: October 25, 2010
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Heart Diseases
Vascular Diseases processed this record on November 25, 2014