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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
  Purpose

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 Intervention
Coronary Artery Disease
 Procedure: Skeletonization of the internal thoracic artery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Skeletonized Versus Non-Skeletonized Internal Thoracic Artery Harvest for Coronary Artery Bypass Grafting

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Ottawa:

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

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

Estimated Enrollment: 48
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00265499

Locations
Canada, Ontario
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Sponsors and Collaborators
University of Ottawa
Investigators
Principal Investigator: Fraser D. Rubens, MD University of Ottawa Heart Institute, Division of Cardiac Surgery
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00265499     History of Changes
Other Study ID Numbers: R03-41
Study First Received: December 13, 2005
Last Updated: December 13, 2005
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Ottawa:
Coronary Artery Bypass
Skeletonization
Internal Thoracic Artery
 Flow
Length
Pain

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

ClinicalTrials.gov processed this record on May 23, 2013