The Internal Thoracic Artery Skeletonization Study: A Paired, Within-Patient Comparison
| Tracking Information | |||||
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| First Received Date ICMJE | December 13, 2005 | ||||
| Last Updated Date | December 13, 2005 | ||||
| Start Date ICMJE | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Intra-operative Internal Thoracic Artery Flow measure prior to coronary anastomoses | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Internal Thoracic Artery Skeletonization Study: A Paired, Within-Patient Comparison | ||||
| Official Title ICMJE | Skeletonized Versus Non-Skeletonized Internal Thoracic Artery Harvest for Coronary Artery Bypass Grafting | ||||
| 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 |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
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| Condition ICMJE | Coronary Artery Disease | ||||
| Intervention ICMJE | Procedure: Skeletonization of the internal thoracic artery | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 48 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00265499 | ||||
| Other Study ID Numbers ICMJE | R03-41 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | University of Ottawa | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Ottawa | ||||
| Verification Date | November 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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