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Completed

NCT Number: NCT00947050

Prompt Human Coronary Collateral Vasomotor Function Induced by Dynamic Physical Exercise

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Bern

Bern, 3010, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dynamic physical exercise

Other

dynamic supine bicycle exercise for 6 minutes

Other names: rest first, ex first

Primary outcomes

  1. Change of collateral flow index (CFI, no unit) during exercise (E) compared to CFI at rest (R).

    Time frame: 6 minutes

Secondary outcomes

  1. Correlation of collateral flow index change and maximal workload.

    Time frame: 6 minutes

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • Swiss National Science Foundation

Registry information

Important dates

Study start
2005
Primary completion
2008
Study completion
2009
First posted
Jul 27, 2009
Registry last updated
Oct 26, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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