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

• Sponsor: University of Ottawa (Other)
• Overall Status: Completed
• CT.gov ID: NCT00265499
• Collaborator: (none)
• Enrollment: 48
• Location: 1

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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

Outcome Measures

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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00265499
• Other Study ID Numbers: R03-41
• First Posted: Dec 14, 2005
• Last Update Posted: Dec 14, 2005
• Last Verified: Nov 1, 2005

• Keywords provided by , ,: Coronary Artery Bypass; Skeletonization; Internal Thoracic Artery; Flow; Length; Pain
• Additional relevant MeSH terms: Coronary Artery Disease

Study Results

No Results Posted as of Dec 14, 2005