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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00265499
Recruitment Status : Completed
First Posted : December 14, 2005
Last Update Posted : December 14, 2005
Information provided by:
University of Ottawa

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Procedure: Skeletonization of the internal thoracic artery Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Skeletonized Versus Non-Skeletonized Internal Thoracic Artery Harvest for Coronary Artery Bypass Grafting

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Intra-operative Internal Thoracic Artery Flow measure prior to coronary anastomoses

Secondary Outcome Measures :
  1. - Internal Thoracic Artery length
  2. - Sternal Perfusion (SPECT imaging)
  3. - Post-operative pain and dysesthesia

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00265499

Canada, Ontario
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Sponsors and Collaborators
University of Ottawa
Principal Investigator: Fraser D. Rubens, MD University of Ottawa Heart Institute, Division of Cardiac Surgery Identifier: NCT00265499     History of Changes
Other Study ID Numbers: R03-41
First Posted: December 14, 2005    Key Record Dates
Last Update Posted: December 14, 2005
Last Verified: November 2005

Keywords provided by University of Ottawa:
Coronary Artery Bypass
Internal Thoracic Artery

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases