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

This study is not yet open for patient recruitment.
Verified by Trillium Health Centre September 2005

Sponsors and Collaborators: Trillium Health Centre
Toshiba Medical Systems
Information provided by: Trillium Health Centre
ClinicalTrials.gov Identifier: NCT00259493

Purpose

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

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment, Efficacy Study

Official Title: Graft Patency Following Off-Pump CABG Vs. On-Pump CABG Using 64 MDCT Bypass Graft CT Angiography

Further study details as provided by Trillium Health Centre:
Primary Outcomes: Graft patency as determined by bypass graft CT angiography at 3 months and 12 months following surgery
Secondary Outcomes: Length of Hospital Stay; Blood Loss; Operative Time; Post-op Complications; Quality of Life Assessment
Expected Total Enrollment:  350

Study start: December 2005;  Expected completion: December 2007
Last follow-up: October 2007;  Data entry closure: October 2007

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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

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.
  • onability to provide written informed consent.
  • prior severe reaction to contrast dye :
  • life-threatening anaphylactoid reactions
  • cardiac dysrrythmias and arrest
  • cardiovascular and pulmonary collapse
  • elevated serum creatinine (>150 mmol/L).
  • contraindications to cardiopulmonary bypass.
  • Age < 18 years .

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00259493

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

Canada, Ontario
      Trillium Health Centre, Mississauga,  Ontario,  L5B 1B8,  Canada

Study chairs or principal investigators

Tarang N Sheth, MD, FRCPC,  Principal Investigator,  Trillium Health Centre   
Gopal Bhatnagar, MD, FRCSC,  Principal Investigator,  Trillium Health Centre   

More Information

Study ID Numbers:  001
Last Updated:  December 8, 2005
Record first received:  November 25, 2005
ClinicalTrials.gov Identifier:  NCT00259493
Health Authority: Canada: Ethics Review Committee
ClinicalTrials.gov processed this record on 2006-01-10



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