Prompt Human Coronary Collateral Vasomotor Function Induced by Dynamic Physical Exercise

October 25, 2010 updated by: University Hospital Inselspital, Berne
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • University Hospital Bern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of collateral flow index (CFI, no unit) during exercise (E) compared to CFI at rest (R).
Time Frame: 6 minutes
6 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation of collateral flow index change and maximal workload.
Time Frame: 6 minutes
6 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Collaborators

Swiss National Science Foundation

Investigators

  • Principal Investigator: Pascal Meier, MD, University of Bern
  • Principal Investigator: Mario Togni, MD, University of Bern
  • Study Chair: Christian Seiler, MD,Prof., University of Bern
  • Principal Investigator: Stefano de Marchi, MD, Univerity of Bern

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

July 24, 2009

First Submitted That Met QC Criteria

July 24, 2009

First Posted (Estimate)

July 27, 2009

Study Record Updates

Last Update Posted (Estimate)

October 26, 2010

Last Update Submitted That Met QC Criteria

October 25, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14/05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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