Coronary Artery Bypass Surgery (CABG) Off or On Pump Revascularization Study

Summary

I. Main Research Question:

* To compare the risks and benefits of Off-pump Coronary artery bypass surgery (CABG) to On-pump CABG and to determine if one is better than the other.
* The purpose of this pilot study is also to see the rate of recruitment with expertise-based randomization across different hospital settings.

II. Small RCT studies and meta-analyses done so far have not been able to conclusively say which of the procedure is better. A large randomized study is required to establish the risks and benefits associated with both the off-pump and on-pump CABG surgical procedures.

III. The study will look at which of the two techniques reduce major risks associated with CABG.

Conditions

• the Efficacy and Safety of Off-pump CABG

Interventions

PROCEDURE

Coronary Artery Bypass Graft with the use of CPB

Coronary Artery Bypass Graft (CABG) using median sternotomy, CPB, cardioplegia and complete cross-clamp and no associated or concomitant surgical procedures

PROCEDURE

Coronary Artery Bypass Graft without the use of CPB

Coronary Artery Bypass Graft (CABG) with no associated or concomitant surgical procedures, using median sternotomy and without CPB and cardioplegia

Sponsors & Collaborators

• McMaster University

  collaborator OTHER

• University of Oxford

  collaborator OTHER

• Instituto Dante Pazzanese de Cardiologia

  collaborator OTHER

• Fu Wai Hospital, Beijing, China

  collaborator OTHER

• Universidad de La Frontera

  collaborator OTHER

• Fundación Cardiovascular de Colombia

  collaborator OTHER

• Charles University, Czech Republic

  collaborator OTHER

• Hopital Jean Minjoz

  collaborator OTHER

• Centre for Chronic Disease Control, India

  collaborator OTHER

• Ospedale Santa Croce-Carle Cuneo

  collaborator OTHER

• Medical University of Gdansk

  collaborator OTHER

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  collaborator OTHER

• Ankara University

  collaborator OTHER

• Hotel Dieu Hospital

  collaborator OTHER

• Centre hospitalier de l'Université de Montréal (CHUM)

  collaborator OTHER

• SAL Hospital, Ahmedabad, India

  collaborator UNKNOWN

• Population Health Research Institute

  lead OTHER

Principal Investigators

• Lamy Andre, MD, MSc · McMaster University

• Salim Yusuf, MD, DPhil · Population Health Research Institute

• David Taggart, MD · University of Oxford

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-10-31

Primary Completion

2012-03-31

Completion

2016-09-30

Countries

• Argentina
• Brazil
• Canada
• Chile
• China
• Colombia
• Czechia
• France
• India
• Italy
• Poland
• Turkey (Türkiye)
• United Kingdom

Study Locations