Prompt Human Coronary Collateral Vasomotor Function Induced by Dynamic Physical Exercise

Coronary Artery Disease Clinical Trial

Official title:

Prompt Human Coronary Collateral Vasomotor Function Induced by Dynamic Physical Exercise

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00947050
• Other study ID #: 14/05
• Status: Completed
• Phase: N/A
• First received: July 24, 2009
• Last updated: October 25, 2010
• Start date: April 2005
• Est. completion date: March 2009

Study information

• Verified date: October 2010
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Other:
• dynamic physical exercise
dynamic supine bicycle exercise for 6 minutes

Locations

Country	Name	City	State
Switzerland	University Hospital Bern	Bern

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of collateral flow index (CFI, no unit) during exercise (E) compared to CFI at rest (R).		6 minutes	Yes
Secondary	Correlation of collateral flow index change and maximal workload.		6 minutes	No