Condition category
Circulatory System
Date applied
22/07/2005
Date assigned
22/07/2005
Last edited
12/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Joseph Brindaban Selvanayagam

ORCID ID

Contact details

John Radcliffe Hospital
MRS Building
University of Oxford Clinical Magnetic Resonance Research Centre
Headley Way
Oxford
OX3 9DU
United Kingdom
+44 (0)1865 221867
joseph.selvanayagam@cardiov.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

066216

Study information

Scientific title

Effects of off pump versus on pump coronary surgery on reversible and irreversible myocardial injury: a randomised trial using cardiovascular magnetic resonance imaging and biochemical markers

Acronym

Study hypothesis

Using Cardiovascular Magnetic Resonance imaging (CMR), we compared the extent of peri-operative myocardial reversible injury (myocardial stunning) and irreversible injury (myocardial necrosis) in patients undergoing multi-vessel Coronary Artery Bypass Graft surgery (CABG) with and without cardiopulmonary bypass, in a single center randomised trial.

To our knowledge, this is the first such study using cine and contrast-enhanced CMR. Furthermore, we correlated these CMR findings with the changes in post operative cardiac Troponin I. Our primary hypothesis was that off pump surgery results in reduced myocardial stunning (as measured by cine MRI) in the early post-operative period when compared to ON-pump CABG (ONCABG) surgery. We further hypothesised that off pump surgery is superior to ONCABG with regards to the extent of permanent myocardial damage and that post-operative myocardial enzyme release reflects myonecrosis.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

CABG surgery

Intervention

Single centre randomised trial comparing off pump (beating heart) versus conventional bypass coronary artery surgery.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

1. Left ventricular function at one week post-op
2. LV function at six months post-op
3. Myocardial necrosis post-op

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/05/2002

Overall trial end date

01/10/2003

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged less than 75 years
2. Isolated coronary grafting

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Age greater than 75 years (ten patients)
2. Ppre-existing Left Ventricular (LV) dysfunction (ejection fraction less than 20% by echocardiogram; four patients)
3. Involvement in other clinical trials (ten patients)
4. Typical MRI contraindications (e.g. pacemaker, severe claustrophobia etc.; total of nine patients)
5. Baseline creatinine more than 200 µmol/L (two patients)

Recruitment start date

01/05/2002

Recruitment end date

01/04/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

University Offices
Wellington Square
Oxford
OX1 2JD
United Kingdom
+44 (0)1865 270143
research.services@admin.ox.ac.uk

Sponsor type

University/education

Website

http://www.ox.ac.uk

Funders

Funder type

Charity

Funder name

Wellcome Trust (UK) (grant ref: 066216)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/14732755

Publication citations

  1. Results

    Selvanayagam JB, Petersen SE, Francis JM, Robson MD, Kardos A, Neubauer S, Taggart DP, Effects of off-pump versus on-pump coronary surgery on reversible and irreversible myocardial injury: a randomized trial using cardiovascular magnetic resonance imaging and biochemical markers., Circulation, 2004, 109, 3, 345-350, doi: 10.1161/01.CIR.0000109489.71945.BD.

Additional files

Editorial Notes