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Completed

NCT Number: NCT00265499

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

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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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Skeletonization of the internal thoracic artery

Procedure

Primary outcomes

  1. Intra-operative Internal Thoracic Artery Flow measure prior to coronary anastomoses

Secondary outcomes

  1. - Internal Thoracic Artery length

  2. - Sternal Perfusion (SPECT imaging)

  3. - Post-operative pain and dysesthesia

Sponsors and collaborators

Lead sponsor

University of Ottawa

Other

Registry information

Official study title

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

Important dates

First posted
Dec 14, 2005
Registry last updated
Dec 14, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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