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

Primary Purpose

Coronary Artery Disease Amenable to Bypass Graft Surgery

Status

Unknown status

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Off-Pump Coronary Artery Bypass Graft Surgery

About this trial

This is an interventional treatment trial for Coronary Artery Disease Amenable to Bypass Graft Surgery focused on measuring Coronary Artery Disease, Coronary Artery Bypass Graft Surgery, Off-pump CABG, Cardiac CT, Bypass Graft CT angiography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 .

Sites / Locations

Trillium Health CentreRecruiting

Outcomes

Primary Outcome Measures

Graft patency as determined by bypass graft CT angiography at 3 months and 12 months following surgery

Secondary Outcome Measures

Length of Hospital Stay

Blood Loss

Operative Time

Post-op Complications

Quality of Life Assessment

Full Information

NCT ID

NCT00259493

First Posted

November 25, 2005

Last Updated

September 7, 2006

Sponsor

Trillium Health Centre

Collaborators

Toshiba America Medical Systems, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00259493

Brief Title

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

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Unknown status

Study Start Date

December 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

October 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Trillium Health Centre

Collaborators

Toshiba America Medical Systems, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Double

Allocation

Randomized

Enrollment

350 (false)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Off-Pump Coronary Artery Bypass Graft Surgery

Primary Outcome Measure Information:

Title

Graft patency as determined by bypass graft CT angiography at 3 months and 12 months following surgery

Secondary Outcome Measure Information:

Title

Length of Hospital Stay

Title

Blood Loss

Title

Operative Time

Title

Post-op Complications

Title

Quality of Life Assessment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kathy Ariss, BSc, RN

Phone

416-400-4753

kariss@thc.on.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tarang N Sheth, MD, FRCPC

Organizational Affiliation

Trillium Health Centre

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Gopal Bhatnagar, MD, FRCSC

Organizational Affiliation

Trillium Health Centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

Trillium Health Centre

City

Mississauga

State/Province

Ontario

ZIP/Postal Code

L5B 1B8

Country

Canada

Individual Site Status

Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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