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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Skeletonization of the internal thoracic artery
Sponsored by
University of Ottawa
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Artery Bypass, Skeletonization, Internal Thoracic Artery, Flow, Length, Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Ottawa Heart Institute

Outcomes

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

Full Information

First Posted
December 13, 2005
Last Updated
December 13, 2005
Sponsor
University of Ottawa
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1. Study Identification

Unique Protocol Identification Number
NCT00265499
Brief Title
The Internal Thoracic Artery Skeletonization Study: A Paired, Within-Patient Comparison
Official Title
Skeletonized Versus Non-Skeletonized Internal Thoracic Artery Harvest for Coronary Artery Bypass Grafting
Study Type
Interventional

2. Study Status

Record Verification Date
November 2005
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Ottawa

4. Oversight

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary Artery Bypass, Skeletonization, Internal Thoracic Artery, Flow, Length, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
48 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Skeletonization of the internal thoracic artery
Primary Outcome Measure Information:
Title
Intra-operative Internal Thoracic Artery Flow measure prior to coronary anastomoses
Secondary Outcome Measure Information:
Title
- Internal Thoracic Artery length
Title
- Sternal Perfusion (SPECT imaging)
Title
- Post-operative pain and dysesthesia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fraser D. Rubens, MD
Organizational Affiliation
University of Ottawa Heart Institute, Division of Cardiac Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada

12. IPD Sharing Statement

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

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