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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Trillium Health Centre.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Toshiba America Medical Systems, Inc.
Information provided by:
Trillium Health Centre
ClinicalTrials.gov Identifier:
NCT00259493
First received: November 25, 2005
Last updated: September 7, 2006
Last verified: September 2005

November 25, 2005
September 7, 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 ClinicalTrials.gov Archive Site
  • Length of Hospital Stay
  • Blood Loss
  • Operative Time
  • Post-op Complications
  • Quality of Life Assessment
Same as current
Not Provided
Not Provided
 
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Coronary Artery Disease Amenable to Bypass Graft Surgery
Procedure: Off-Pump Coronary Artery Bypass Graft Surgery
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
350
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 .
Both
18 Years and older
No
Contact: Kathy Ariss, BSc, RN 416-400-4753 kariss@thc.on.ca
Canada
 
NCT00259493
001
Not Provided
Not Provided
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