- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00265499
The Internal Thoracic Artery Skeletonization Study: A Paired, Within-Patient Comparison
December 13, 2005 updated by: University of Ottawa
Skeletonized Versus Non-Skeletonized Internal Thoracic Artery Harvest for Coronary Artery Bypass Grafting
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada, K1Y 4W7
- University of Ottawa Heart Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Intra-operative Internal Thoracic Artery Flow measure prior to coronary anastomoses
|
Secondary Outcome Measures
Outcome Measure |
---|
- Internal Thoracic Artery length
|
- Sternal Perfusion (SPECT imaging)
|
- Post-operative pain and dysesthesia
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Fraser D. Rubens, MD, University of Ottawa Heart Institute, Division of Cardiac Surgery
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
December 13, 2005
First Submitted That Met QC Criteria
December 13, 2005
First Posted (Estimate)
December 14, 2005
Study Record Updates
Last Update Posted (Estimate)
December 14, 2005
Last Update Submitted That Met QC Criteria
December 13, 2005
Last Verified
November 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R03-41
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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