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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
History of Changes
  Purpose

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.


Condition Intervention
Coronary Artery Disease
 Other: dynamic physical exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Prompt Human Coronary Collateral Vasomotor Function Induced by Dynamic Physical Exercise

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Correlation of collateral flow index change and maximal workload. [ Time Frame: 6 minutes ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: April 2005
Study Completion Date: March 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: rest first
rest first, cfi, exercise, cfi
 Other: dynamic physical exercise
dynamic supine bicycle exercise for 6 minutes
Other Names:
  • rest first
  • ex first
Active Comparator: exercise first
ex first
 Other: dynamic physical exercise
dynamic supine bicycle exercise for 6 minutes
Other Names:
  • rest first
  • ex first

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00947050

Locations
Switzerland
University Hospital Bern
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Swiss National Science Foundation
Investigators
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
  More Information

No publications provided

Responsible Party: University hospital Bern, Cardiology
ClinicalTrials.gov Identifier: NCT00947050     History of Changes
Other Study ID Numbers: 14/05
Study First Received: July 24, 2009
Last Updated: October 25, 2010
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:
CAD
prompt physical exercise
collateral function

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 May 19, 2013