The Internal Thoracic Artery Skeletonization Study: A Paired, Within-Patient Comparison

This study has been completed.
Sponsor:
Information provided by:
University of Ottawa
ClinicalTrials.gov Identifier:
NCT00265499
First received: December 13, 2005
Last updated: NA
Last verified: November 2005
History: No changes posted

December 13, 2005
December 13, 2005
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Not Provided
Intra-operative Internal Thoracic Artery Flow measure prior to coronary anastomoses
Same as current
No Changes Posted
  • - Internal Thoracic Artery length
  • - Sternal Perfusion (SPECT imaging)
  • - Post-operative pain and dysesthesia
Same as current
Not Provided
Not Provided
 
The Internal Thoracic Artery Skeletonization Study: A Paired, Within-Patient Comparison
Skeletonized Versus Non-Skeletonized Internal Thoracic Artery Harvest for Coronary Artery Bypass Grafting

The purpose of this study is to determine whether skeletonization of the internal thoracic artery leads to improved flow, increased length, improved sternal perfusion, and decreased pain and dysesthesia in patients undergoing coronary artery bypass surgery

Traditional harvesting of the internal thoracic artery (ITA) for use as a conduit in coronary bypass surgery involves the dissection of a rim of tissue surrounding the artery on either side. Although the benefits of ITA use are well established, there are certain limitations to its routine use. Recent studies, primarily observational, have suggested that skeletonization of the ITA (i.e. harvesting of the ITA alone) may overcome some of these limitations by improving conduit flow, increasing length, and reducing the risk of deep sternal infection in high risk patients. Furthermore, skeletonization of the ITA can potentially preserve intercostal nerves and reduce post-operative pain and dysesthesias associated with ITA harvesting. In order to assess the effects of ITA skeletonization, this is a prospective, randomized, within-patient study design in patients undergoing coronary artery bypass grafting.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Coronary Artery Disease
Procedure: Skeletonization of the internal thoracic artery
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
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Inclusion Criteria:

  • Patients undergoing bilateral internal thoracic artery harvest for coronary artery bypass surgery

Exclusion Criteria:

  • Inability to speak English or French
  • Inability to complete follow-up visits
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00265499
R03-41
Not Provided
Not Provided
University of Ottawa
Not Provided
Principal Investigator: Fraser D. Rubens, MD University of Ottawa Heart Institute, Division of Cardiac Surgery
University of Ottawa
November 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP