NCT00265499

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 14, 2005

Completed
Last Updated

December 14, 2005

Status Verified

November 1, 2005

First QC Date

December 13, 2005

Last Update Submit

December 13, 2005

Conditions

Keywords

Coronary Artery BypassSkeletonizationInternal Thoracic ArteryFlowLengthPain

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

  • - Internal Thoracic Artery length

  • - Sternal Perfusion (SPECT imaging)

  • - Post-operative pain and dysesthesia

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing bilateral internal thoracic artery harvest for coronary artery bypass surgery

You may not qualify if:

  • Inability to speak English or French
  • Inability to complete follow-up visits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

MeSH Terms

Conditions

Coronary Artery DiseasePain

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Fraser D. Rubens, MD

    University of Ottawa Heart Institute, Division of Cardiac Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 13, 2005

First Posted

December 14, 2005

Last Updated

December 14, 2005

Record last verified: 2005-11

Locations