Prompt Human Coronary Collateral Vasomotor Function Induced by Dynamic Physical Exercise
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
dynamic physical exercise
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring CAD, prompt physical exercise, collateral function
Eligibility 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
Sites / Locations
- University Hospital Bern
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
rest first
exercise first
Arm Description
rest first, cfi, exercise, cfi
ex first
Outcomes
Primary Outcome Measures
Change of collateral flow index (CFI, no unit) during exercise (E) compared to CFI at rest (R).
Secondary Outcome Measures
Correlation of collateral flow index change and maximal workload.
Full Information
NCT ID
NCT00947050
First Posted
July 24, 2009
Last Updated
October 25, 2010
Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Swiss National Science Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00947050
Brief Title
Prompt Human Coronary Collateral Vasomotor Function Induced by Dynamic Physical Exercise
Official Title
Prompt Human Coronary Collateral Vasomotor Function Induced by Dynamic Physical Exercise
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Swiss National Science Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
CAD, prompt physical exercise, collateral function
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rest first
Arm Type
Active Comparator
Arm Description
rest first, cfi, exercise, cfi
Arm Title
exercise first
Arm Type
Active Comparator
Arm Description
ex first
Intervention Type
Other
Intervention Name(s)
dynamic physical exercise
Other Intervention Name(s)
rest first, ex first
Intervention Description
dynamic supine bicycle exercise for 6 minutes
Primary Outcome Measure Information:
Title
Change of collateral flow index (CFI, no unit) during exercise (E) compared to CFI at rest (R).
Time Frame
6 minutes
Secondary Outcome Measure Information:
Title
Correlation of collateral flow index change and maximal workload.
Time Frame
6 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steffen Gloekler, MD
Organizational Affiliation
University of Bern
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mario Togni, MD
Organizational Affiliation
University of Bern
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pascal Meier, MD
Organizational Affiliation
University of Bern
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christian Seiler, MD,Prof.
Organizational Affiliation
University of Bern
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Stefano de Marchi, MD
Organizational Affiliation
Univerity of Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
20584776
Citation
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.
Results Reference
derived
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Prompt Human Coronary Collateral Vasomotor Function Induced by Dynamic Physical Exercise
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