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Graft Patency in Beating Heart Vs. Conventional CABG Using Cardiac CT

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by Trillium Health Centre.
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: November 29, 2005
Last Update Posted: September 11, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Toshiba America Medical Systems, Inc.
Information provided by:
Trillium Health Centre
The purpose of this study is to compare graft patency rates following coronary artery bypass graft surgery performed by beating heart vs. conventional techniques using cardiac CT scanning to evaluate the bypass grafts.

Condition Intervention
Coronary Artery Disease Amenable to Bypass Graft Surgery Procedure: Off-Pump Coronary Artery Bypass Graft Surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Graft Patency Following Off-Pump CABG Vs. On-Pump CABG Using 64 MDCT Bypass Graft CT Angiography

Resource links provided by NLM:

Further study details as provided by Trillium Health Centre:

Primary Outcome Measures:
  • Graft patency as determined by bypass graft CT angiography at 3 months and 12 months following surgery

Secondary Outcome Measures:
  • Length of Hospital Stay
  • Blood Loss
  • Operative Time
  • Post-op Complications
  • Quality of Life Assessment

Estimated Enrollment: 350
Study Start Date: December 2005
Estimated Study Completion Date: October 2007
Detailed Description:

The issue of whether to perform conventional CABG or off-pump CABG continues to be the subject of debate. Controversy remains regarding the appropriateness of applying OPCAB to all patients as opposed to selected sub-populations.

The main strategy of CABG is to obtain complete revascularization with the least morbidity and highest long-term patency rates. Current medical literature is conflicted regarding graft patency rates in OPCAB vs. conventional CABG. Data is also limited due to patient refusal for conventional angiography to assess grafts following surgery. Cardiac computed tomography (CT) offers a non-invasive method to assess graft patency that is 100% accurate for the diagnosis of graft patency vs. occlusion. This study is a prospective randomized controlled trial evaluating graft patency in on-pump vs. off-pump CABG using cardiac CT scanning. The study hypothesis is that graft patency rates will be equivalent between the two techniques.


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Surgery indicated
  • Patient is hemodynamically stable
  • Isolated coronary artery surgery (no valve)
  • No contraindications to cardiopulmonary bypass
  • No previous surgery (not redo CABG)

Exclusion Criteria:

  • critically ill patient with hemodynamic instability.
  • concomitant cardiac procedures.
  • inability to provide written informed consent.
  • prior severe reaction to contrast dye :
  • life-threatening anaphylactoid reactions
  • cardiac dysrhythmias and arrest
  • cardiovascular and pulmonary collapse
  • elevated serum creatinine (>150 mmol/L).
  • contraindications to cardiopulmonary bypass.
  • Age < 18 years .
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00259493

Contact: Kathy Ariss, BSc, RN 416-400-4753 kariss@thc.on.ca

Canada, Ontario
Trillium Health Centre Recruiting
Mississauga, Ontario, Canada, L5B 1B8
Sponsors and Collaborators
Trillium Health Centre
Toshiba America Medical Systems, Inc.
Principal Investigator: Tarang N Sheth, MD, FRCPC Trillium Health Centre
Principal Investigator: Gopal Bhatnagar, MD, FRCSC Trillium Health Centre
  More Information

ClinicalTrials.gov Identifier: NCT00259493     History of Changes
Other Study ID Numbers: 001
First Submitted: November 25, 2005
First Posted: November 29, 2005
Last Update Posted: September 11, 2006
Last Verified: September 2005

Keywords provided by Trillium Health Centre:
Coronary Artery Disease
Coronary Artery Bypass Graft Surgery
Off-pump CABG
Cardiac CT
Bypass Graft CT angiography

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases