Prompt Human Coronary Collateral Vasomotor Function Induced by Dynamic Physical Exercise
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 PCI (percutaneous coronary intervention) is to evaluate if dynamic physical exercise leads to an instantaneous improvement of coronary collateral function.
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 Apr 2005
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
April 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 24, 2009
CompletedFirst Posted
Study publicly available on registry
July 27, 2009
CompletedOctober 26, 2010
October 1, 2010
3.7 years
July 24, 2009
October 25, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of collateral flow index (CFI, no unit) during exercise (E) compared to CFI at rest (R).
6 minutes
Secondary Outcomes (1)
Correlation of collateral flow index change and maximal workload.
6 minutes
Study Arms (2)
rest first
ACTIVE COMPARATORrest first, cfi, exercise, cfi
exercise first
ACTIVE COMPARATORex first
Interventions
dynamic supine bicycle exercise for 6 minutes
Eligibility Criteria
You may qualify if:
- Age more than or 18 years old
- to 3-vessel coronary artery disease (CAD)
- Stable angina pectoris
- At least 1 stenotic lesion suitable for PCI
- Negative Allen-test
- Written informed consent to participate in the study
You may not qualify if:
- Patients admitted as emergencies
- Acute myocardial infarction
- Unstable CAD
- Q-wave myocardial infarction in the area undergoing CFI measurement
- CAD treated best by CABG
- Severe valve disease
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Bern
Bern, 3010, Switzerland
Related Publications (1)
Togni M, Gloekler S, Meier P, de Marchi SF, Rutz T, Steck H, Traupe T, Seiler C. Instantaneous coronary collateral function during supine bicycle exercise. Eur Heart J. 2010 Sep;31(17):2148-55. doi: 10.1093/eurheartj/ehq202. Epub 2010 Jun 28.
PMID: 20584776DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steffen Gloekler, MD
University of Bern
- PRINCIPAL INVESTIGATOR
Mario Togni, MD
University of Bern
- PRINCIPAL INVESTIGATOR
Pascal Meier, MD
University of Bern
- STUDY CHAIR
Christian Seiler, MD,Prof.
University of Bern
- PRINCIPAL INVESTIGATOR
Stefano de Marchi, MD
Univerity of Bern
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 24, 2009
First Posted
July 27, 2009
Study Start
April 1, 2005
Primary Completion
December 1, 2008
Study Completion
March 1, 2009
Last Updated
October 26, 2010
Record last verified: 2010-10