Prompt Human Coronary Collateral Vasomotor Function Induced by Dynamic Physical Exercise

This study has been completed.
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00947050
First received: July 24, 2009
Last updated: October 25, 2010
Last verified: October 2010

July 24, 2009
October 25, 2010
April 2005
December 2008   (final data collection date for primary outcome measure)
Change of collateral flow index (CFI, no unit) during exercise (E) compared to CFI at rest (R). [ Time Frame: 6 minutes ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00947050 on ClinicalTrials.gov Archive Site
Correlation of collateral flow index change and maximal workload. [ Time Frame: 6 minutes ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Prompt Human Coronary Collateral Vasomotor Function Induced by Dynamic Physical Exercise
Prompt Human Coronary Collateral Vasomotor Function Induced by Dynamic Physical Exercise

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.

The existence of coronary collateral vessels and their benefit against cardiac events have been recognized for many years, but their functional capacity in response to physical exercise has partially remained elusive. Via endothelial shear stress, the fundamental stimulus for collateral development, exercise theoretically leads to collateral vasodilation and recruitment by an increase in heart rate and blood pressure during exercise. Moreover, the phenomenon of "walking through angina" indicates that collateral function and physical activity are related and their interaction is of clinical relevance.

The purpose of the present study in humans with stable coronary artery disease was to assess the instantaneous response of coronary collateral function to dynamic physical exercise.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Coronary Artery Disease
Other: dynamic physical exercise
dynamic supine bicycle exercise for 6 minutes
Other Names:
  • rest first
  • ex first
  • Active Comparator: rest first
    rest first, cfi, exercise, cfi
    Intervention: Other: dynamic physical exercise
  • Active Comparator: exercise first
    ex first
    Intervention: Other: dynamic physical exercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
March 2009
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age more than or 18 years old
  • 1- 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

Exclusion Criteria:

  • 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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00947050
14/05
Yes
University hospital Bern, Cardiology
University Hospital Inselspital, Berne
Swiss National Science Foundation
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
University Hospital Inselspital, Berne
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP