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

Coronary Artery Disease Amenable to Bypass Graft Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00259493
• Other study ID #: 001
• Status: Recruiting
• Phase: N/A
• First received: November 25, 2005
• Last updated: September 7, 2006
• Start date: December 2005
• Est. completion date: October 2007

Study information

• Verified date: September 2005
• Source: Trillium Health Centre
• Contact: Kathy Ariss, BSc, RN
• Phone: 416-400-4753
• Email: kariss[@]thc.on.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 .

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Disease Amenable to Bypass Graft Surgery
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Off-Pump Coronary Artery Bypass Graft Surgery

Locations

Country	Name	City	State
Canada	Trillium Health Centre	Mississauga	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Trillium Health Centre	Toshiba America Medical Systems, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Graft patency as determined by bypass graft CT angiography at 3 months and 12 months following surgery
Secondary	Length of Hospital Stay
Secondary	Blood Loss
Secondary	Operative Time
Secondary	Post-op Complications
Secondary	Quality of Life Assessment