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

This study is currently recruiting participants.
Verified by Trillium Health Centre, September 2005

Sponsors and Collaborators: Trillium Health Centre
Toshiba Medical Systems
Information provided by: Trillium Health Centre
ClinicalTrials.gov Identifier: NCT00259493
  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

MedlinePlus related topics:   Coronary Artery Bypass Surgery    Coronary Artery Disease   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment, Efficacy Study
Official Title:   Graft Patency Following Off-Pump CABG Vs. On-Pump CABG Using 64 MDCT Bypass Graft CT Angiography

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 Medical Systems

Investigators
Principal Investigator:     Tarang N Sheth, MD, FRCPC     Trillium Health Centre    
Principal Investigator:     Gopal Bhatnagar, MD, FRCSC     Trillium Health Centre    
  More Information


Study ID Numbers:   001
First Received:   November 25, 2005
Last Updated:   September 7, 2006
ClinicalTrials.gov Identifier:   NCT00259493
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  

Study placed in the following topic categories:
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 06, 2008




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