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

Coronary Artery Disease Clinical Trial

Official title:

Skeletonized Versus Non-Skeletonized Internal Thoracic Artery Harvest for Coronary Artery Bypass Grafting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00265499
• Other study ID #: R03-41
• Status: Completed
• Phase: N/A
• First received: December 13, 2005
• Last updated: December 13, 2005

Study information

• Verified date: November 2005
• Source: University of Ottawa
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Skeletonization of the internal thoracic artery

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Ottawa

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra-operative Internal Thoracic Artery Flow measure prior to coronary anastomoses
Secondary	- Internal Thoracic Artery length
Secondary	- Sternal Perfusion (SPECT imaging)
Secondary	- Post-operative pain and dysesthesia