Recruiting

Beating Heart vs. Conventional Techniques

Sponsor:

Trillium Health Centre

Code:

NCT00259493

Conditions

Coronary Artery Disease Amenable to Bypass Graft Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Off-Pump Coronary Artery Bypass Graft Surgery

Study Details

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.

Conditions

Coronary Artery Disease Amenable to Bypass Graft Surgery

Study ID

NCT00259493

Start date

Dec, 2005

Status verified date

Sep, 2005

Completion date

Oct, 2007

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

350 participants

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Off-Pump Coronary Artery Bypass Graft Surgery

Primary outcome measure

  • Graft patency as determined by bypass graft CT angiography at 3 months and 12 months following surgery [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Kathy Ariss, BSc, RN

416-400-4753kariss@thc.on.ca

Locations

Trillium Health Centre

Recruiting

Mississauga, Ontario, Canada, L5B 1B8

More Information

Sponsor

Trillium Health Centre

Last update posted

Sep 11, 2006

Last verified

Sep, 2005

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Trillium Health Centre on 2006-09-11.