External Counterpulsation (ECP) for the Promotion of Collateral Growth in Patients With Coronary Artery Disease
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable coronary-artery-disease
Started Aug 2006
Typical duration for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 20, 2006
CompletedFirst Posted
Study publicly available on registry
December 21, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedOctober 26, 2010
October 1, 2010
2.3 years
December 20, 2006
October 25, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Collateral flow index (CFI)
21 days
Coronary collateral resistance (Rcoll)
21 days
Secondary Outcomes (1)
Myocardial perfusion reserve
21 days
Study Arms (2)
1 ECP
ACTIVE COMPARATORactive ECP Therapy
2
PLACEBO COMPARATORSham ECP Treatment
Interventions
Eligibility Criteria
You may qualify if:
- Age \> 18 years old
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bern University Hospital
Bern, 3010, Switzerland
Related Publications (1)
Al Kaabi A, Traupe T, Stutz M, Buchs N, Heller M. Cause or effect of arteriogenesis: compositional alterations of microparticles from CAD patients undergoing external counterpulsation therapy. PLoS One. 2012;7(10):e46822. doi: 10.1371/journal.pone.0046822. Epub 2012 Oct 8.
PMID: 23056467DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Christian Seiler, MD, Prof.
University of Bern
- PRINCIPAL INVESTIGATOR
Steffen Gloekler, MD
University of Bern
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 20, 2006
First Posted
December 21, 2006
Study Start
August 1, 2006
Primary Completion
December 1, 2008
Study Completion
June 1, 2009
Last Updated
October 26, 2010
Record last verified: 2010-10