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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Trillium Health Centre.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Toshiba America Medical Systems, Inc.
Information provided by:
Trillium Health Centre
ClinicalTrials.gov Identifier:
NCT00259493
First received: November 25, 2005
Last updated: September 7, 2006
Last verified: September 2005
  Purpose

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.


Condition Intervention
Coronary Artery Disease Amenable to Bypass Graft Surgery
Procedure: Off-Pump Coronary Artery Bypass Graft Surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Graft Patency Following Off-Pump CABG Vs. On-Pump CABG Using 64 MDCT Bypass Graft CT Angiography

Resource links provided by NLM:


Further study details as provided by Trillium Health Centre:

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

Estimated Enrollment: 350
Study Start Date: December 2005
Estimated Study Completion Date: October 2007
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 .
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00259493

Contacts
Contact: Kathy Ariss, BSc, RN 416-400-4753 kariss@thc.on.ca

Locations
Canada, Ontario
Trillium Health Centre Recruiting
Mississauga, Ontario, Canada, L5B 1B8
Sponsors and Collaborators
Trillium Health Centre
Toshiba America Medical Systems, Inc.
Investigators
Principal Investigator: Tarang N Sheth, MD, FRCPC Trillium Health Centre
Principal Investigator: Gopal Bhatnagar, MD, FRCSC Trillium Health Centre
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00259493     History of Changes
Other Study ID Numbers: 001
Study First Received: November 25, 2005
Last Updated: September 7, 2006
Health Authority: Canada: Ethics Review Committee

Keywords provided by Trillium Health Centre:
Coronary Artery Disease
Coronary Artery Bypass Graft Surgery
Off-pump CABG
Cardiac CT
Bypass Graft CT angiography

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014