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

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. Identifier: NCT00259493
Recruitment Status : Unknown
Verified September 2005 by Trillium Health Centre.
Recruitment status was:  Recruiting
First Posted : November 29, 2005
Last Update Posted : September 11, 2006
Toshiba America Medical Systems, Inc.
Information provided by:
Trillium Health Centre

November 25, 2005
November 29, 2005
September 11, 2006
December 2005
Not Provided
Graft patency as determined by bypass graft CT angiography at 3 months and 12 months following surgery
Same as current
Complete list of historical versions of study NCT00259493 on Archive Site
  • Length of Hospital Stay
  • Blood Loss
  • Operative Time
  • Post-op Complications
  • Quality of Life Assessment
Same as current
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Graft Patency in Beating Heart Vs. Conventional CABG Using Cardiac CT
Graft Patency Following Off-Pump CABG Vs. On-Pump CABG Using 64 MDCT Bypass Graft CT Angiography
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.

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.

Not Applicable
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Coronary Artery Disease Amenable to Bypass Graft Surgery
Procedure: Off-Pump Coronary Artery Bypass Graft Surgery
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
October 2007
Not Provided

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 .
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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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
Trillium Health Centre
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP