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

NCT ID: NCT00259493

Last Updated: 2006-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2007-10-31

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease Amenable to Bypass Graft Surgery

Keywords

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Coronary Artery Disease Coronary Artery Bypass Graft Surgery Off-pump CABG Cardiac CT Bypass Graft CT angiography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Off-Pump Coronary Artery Bypass Graft Surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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 .
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Toshiba America Medical Systems, Inc.

INDUSTRY

Sponsor Role collaborator

Trillium Health Centre

OTHER

Sponsor Role lead

Principal Investigators

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Tarang N Sheth, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Trillium Health Centre

Gopal Bhatnagar, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

Trillium Health Centre

Locations

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Trillium Health Centre

Mississauga, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Kathy Ariss, BSc, RN

Role: CONTACT

Phone: 416-400-4753

Email: [email protected]

Other Identifiers

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001

Identifier Type: -

Identifier Source: org_study_id