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

Not Applicable

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT00265499
• Lead Sponsor: 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

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 Timeline

• Status Verified: 2005-11
• Study First Submitted: 2005-12-13
• Study First Submitted QC: 2005-12-13
• Last Update Submitted: 2005-12-13
• Study First Posted: 2005-12-14
• Last Update Posted: 2005-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Intra-operative Internal Thoracic Artery Flow measure prior to coronary anastomoses

Secondary Outcome Measures

Name	Time	Method
- Internal Thoracic Artery length
- Sternal Perfusion (SPECT imaging)
- Post-operative pain and dysesthesia

Trial Locations

Locations (1)

University of Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada