Clinical trial NCT00259493: Graft Patency in Beating Heart Vs. Conventional CABG Using Cardiac CT
Official title: Graft Patency Following Off-Pump CABG Vs. On-Pump CABG Using 64 MDCT Bypass Graft CT Angiography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease Amenable to Bypass Graft Surgery
Keywords: Coronary Artery Disease
Coronary Artery Bypass Graft Surgery
Off-pump CABG
Cardiac CT
Bypass Graft CT angiography
Lead sponsor: Trillium Health Centre
Sponsor class: OTHER
Collaborators: name: Toshiba America Medical Systems, Inc.
First posted: 2005-11-29
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility 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.
* 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 .

Primary outcomes:
measure: Graft patency as determined by bypass graft CT angiography at 3 months and 12 months following surgery
Secondary outcomes:
measure: Length of Hospital Stay
measure: Blood Loss
measure: Operative Time
measure: Post-op Complications
measure: Quality of Life Assessment
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Trillium Health Centre
state: Ontario
Study officials:
affiliation: Trillium Health Centre
name: Tarang N Sheth, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Trillium Health Centre
name: Gopal Bhatnagar, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: