Clinical trial NCT00947050: 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
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: CAD
prompt physical exercise
collateral function
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2009-07-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Change of collateral flow index (CFI, no unit) during exercise (E) compared to CFI at rest (R).
timeFrame: 6 minutes
Secondary outcomes:
measure: Correlation of collateral flow index change and maximal workload.
timeFrame: 6 minutes
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University Hospital Bern
Study officials:
affiliation: University of Bern
name: Steffen Gloekler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bern
name: Mario Togni, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bern
name: Pascal Meier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bern
name: Christian Seiler, MD,Prof.
role: STUDY_CHAIR
affiliation: Univerity of Bern
name: Stefano de Marchi, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.