NCT00259493

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 29, 2005

Completed
2 days until next milestone

Study Start

First participant enrolled

December 1, 2005

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

September 11, 2006

Status Verified

September 1, 2005

First QC Date

November 25, 2005

Last Update Submit

September 7, 2006

Conditions

Coronary Artery Disease Amenable to Bypass Graft Surgery

Keywords

Coronary Artery DiseaseCoronary Artery Bypass Graft SurgeryOff-pump CABGCardiac CTBypass Graft CT angiography

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

  • Length of Hospital Stay

  • Blood Loss

  • Operative Time

  • Post-op Complications

  • Quality of Life Assessment

Interventions

Off-Pump Coronary Artery Bypass Graft SurgeryPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Surgery indicated
  • Patient is hemodynamically stable
  • Isolated coronary artery surgery (no valve)
  • No contraindications to cardiopulmonary bypass
  • No previous surgery (not redo CABG)

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trillium Health Centre

Mississauga, Ontario, L5B 1B8, Canada

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Tarang N Sheth, MD, FRCPC

    Trillium Health Centre

    PRINCIPAL INVESTIGATOR

  • Gopal Bhatnagar, MD, FRCSC

    Trillium Health Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathy Ariss, BSc, RN

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 25, 2005

First Posted

November 29, 2005

Study Start

December 1, 2005

Study Completion

October 1, 2007

Last Updated

September 11, 2006

Record last verified: 2005-09

Locations

CA(1)