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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:
ClinicalTrials.gov Identifier:
NCT00414297
First Posted: December 21, 2006
Last Update Posted: October 26, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital Inselspital, Berne
  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
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Collateral flow index (CFI) [ Time Frame: 21 days ]
  • Coronary collateral resistance (Rcoll) [ Time Frame: 21 days ]

Secondary Outcome Measures:
  • Myocardial perfusion reserve [ Time Frame: 21 days ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: December 20, 2006
First Posted: December 21, 2006
Last Update Posted: October 26, 2010
Last Verified: October 2010

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