Graft Patency in Beating Heart Vs. Conventional CABG Using Cardiac CT - Article CABG
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
|Coronary Artery Disease Amenable to Bypass Graft Surgery || Procedure: Off-Pump Coronary Artery Bypass Graft Surgery |
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Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment, Efficacy Study
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.
- Surgery indicated
- Patient is hemodynamically stable
- Isolated coronary artery surgery (no valve)
- No contraindications to cardiopulmonary bypass
- No previous surgery (not redo CABG)
- 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
Trillium Health Centre, Mississauga, Ontario, L5B 1B8, Canada
Tarang N Sheth, MD, FRCPC, Principal Investigator, Trillium Health Centre
Gopal Bhatnagar, MD, FRCSC, Principal Investigator, Trillium Health Centre
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