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Prompt Human Coronary Collateral Vasomotor Function Induced by Dynamic Physical Exercise

NCT ID: NCT00947050

Last Updated: 2010-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2009-03-31

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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rest first

rest first, cfi, exercise, cfi

Group Type ACTIVE_COMPARATOR

dynamic physical exercise

Intervention Type OTHER

dynamic supine bicycle exercise for 6 minutes

exercise first

ex first

Group Type ACTIVE_COMPARATOR

dynamic physical exercise

Intervention Type OTHER

dynamic supine bicycle exercise for 6 minutes

Interventions

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dynamic physical exercise

dynamic supine bicycle exercise for 6 minutes

Intervention Type OTHER

Other Intervention Names

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rest first ex first

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swiss National Science Foundation

OTHER

Sponsor Role collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Cardiology

Principal Investigators

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Steffen Gloekler, MD

Role: PRINCIPAL_INVESTIGATOR

University of Bern

Mario Togni, MD

Role: PRINCIPAL_INVESTIGATOR

University of Bern

Pascal Meier, MD

Role: PRINCIPAL_INVESTIGATOR

University of Bern

Christian Seiler, MD,Prof.

Role: STUDY_CHAIR

University of Bern

Stefano de Marchi, MD

Role: PRINCIPAL_INVESTIGATOR

Univerity of Bern

Locations

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University Hospital Bern

Bern, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 20584776 (View on PubMed)

Other Identifiers

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14/05

Identifier Type: -

Identifier Source: org_study_id