NCT00120991

Brief Summary

There is evidence linking cardiopulmonary bypass to negative side effects when used for coronary artery bypass grafting. Coronary artery bypass grafting can be performed without the use of cardiopulmonary bypass. The purpose of this study is to determine the positive and negative effects of coronary artery bypass grafting with or without the use of cardiopulmonary bypass. The patients will be followed at least one year after surgery.

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
341

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2002

Longer than P75 for phase_3

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2005

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 19, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

March 3, 2008

Status Verified

February 1, 2008

Enrollment Period

3.9 years

First QC Date

July 8, 2005

Last Update Submit

February 29, 2008

Conditions

Heart DiseaseCardiovascular Disease

Keywords

Coronary artery bypass graftingOPCAB

Outcome Measures

Primary Outcomes (6)

  • All cause mortality

    Short and long term

  • Acute myocardial infarction

  • Cardiac arrest with successful resuscitation

  • Low cardiac output syndrome/cardiogenic shock

  • Stroke

  • Need for renewed cardiac revascularization procedure

Secondary Outcomes (12)

  • Hyper dynamic shock

  • Atrial fibrillation during index admission

  • Need for pacing > 24 hours

  • Renal complications, i.e., increased serum creatinine

  • Reoperation for bleeding during index admission

  • +7 more secondary outcomes

Interventions

Coronary artery bypass graftingPROCEDURE

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Known ischemic three vessel heart disease affecting one of the marginal coronary arteries
  • Age \> 54 years
  • Scheduled for elective or subacute CABG
  • EuroSCORE \> 4 and \< 17
  • The patient has signed written informed consent before randomization and surgery.

You may not qualify if:

  • Previous heart surgery
  • Ejection fraction \< 30 %
  • Unstable preoperative condition, i.e., continuous infusion of inotropics on the day of the operation
  • Patient unable to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. Cardiothoracic Surgery, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (3)

  • Moller CH, Perko MJ, Lund JT, Andersen LW, Kelbaek H, Madsen JK, Winkel P, Gluud C, Steinbruchel DA. Three-year follow-up in a subset of high-risk patients randomly assigned to off-pump versus on-pump coronary artery bypass surgery: the Best Bypass Surgery trial. Heart. 2011 Jun;97(11):907-13. doi: 10.1136/hrt.2010.211680. Epub 2011 Mar 17.

    PMID: 21415073DERIVED

  • Moller CH, Perko MJ, Lund JT, Andersen LW, Kelbaek H, Madsen JK, Winkel P, Gluud C, Steinbruchel DA. No major differences in 30-day outcomes in high-risk patients randomized to off-pump versus on-pump coronary bypass surgery: the best bypass surgery trial. Circulation. 2010 Feb 2;121(4):498-504. doi: 10.1161/CIRCULATIONAHA.109.880443. Epub 2010 Jan 18.

    PMID: 20083683DERIVED

  • Jensen BO, Rasmussen LS, Steinbruchel DA. Cognitive outcomes in elderly high-risk patients 1 year after off-pump versus on-pump coronary artery bypass grafting. A randomized trial. Eur J Cardiothorac Surg. 2008 Nov;34(5):1016-21. doi: 10.1016/j.ejcts.2008.07.053. Epub 2008 Sep 7.

    PMID: 18778948DERIVED

MeSH Terms

Conditions

Heart DiseasesCardiovascular Diseases

Interventions

Coronary Artery Bypass

Intervention Hierarchy (Ancestors)

Myocardial RevascularizationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeVascular GraftingVascular Surgical ProceduresThoracic Surgical Procedures

Study Officials

  • Christian H. Møller, MD

    Dept. of Cardiothoracic Surgery and Copenhagen Trial Unit, Rigshospitalet, Copenhagen

    PRINCIPAL INVESTIGATOR

  • Daniel A. Steinbrüchel, Professor

    Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen

    STUDY DIRECTOR

  • Christian Gluud, Consultant

    Copenhagen Trial Unit, Rigshospitalet, Copenhagen

    STUDY CHAIR

  • Jan K. Madsen, Consultant

    Dept. of Cardiology, Amtssygehuset i Gentofte, Copenhagen

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 8, 2005

First Posted

July 19, 2005

Study Start

April 1, 2002

Primary Completion

March 1, 2006

Study Completion

July 1, 2008

Last Updated

March 3, 2008

Record last verified: 2008-02

Locations

DK(1)