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

This study has been completed.
Sponsor:
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00414297
First received: December 20, 2006
Last updated: October 25, 2010
Last verified: October 2010
History of Changes
  Purpose

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

Resource links provided by NLM:

U.S. FDA Resources

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 .

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00414297

Locations
Switzerland
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
  More Information

No publications provided by University Hospital Inselspital, Berne

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: BernUniversity Hospital, Cardiology
ClinicalTrials.gov 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:
CAD
ECP
CFI
CPI
MPR

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013