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

ISRCTN	ISRCTN20472718
DOI	https://doi.org/10.1186/ISRCTN20472718
Protocol serial number	066216
Sponsor	University of Oxford (UK)
Funder	Wellcome Trust (UK) (grant ref: 066216)

Submission date: 22/07/2005
Registration date: 22/07/2005
Last edited: 12/06/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Joseph Brindaban Selvanayagam
Scientific

John Radcliffe Hospital
MRS Building
University of Oxford Clinical Magnetic Resonance Research Centre
Headley Way
Oxford
OX3 9DU
United Kingdom

Phone	+44 (0)1865 221867
Email	joseph.selvanayagam@cardiov.ox.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	CABG surgery
Intervention	Single centre randomised trial comparing off pump (beating heart) versus conventional bypass coronary artery surgery.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	1. Left ventricular function at one week post-op 2. LV function at six months post-op 3. Myocardial necrosis post-op
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	01/10/2003

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	50
Key inclusion criteria	1. Aged less than 75 years 2. Isolated coronary grafting
Key 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)
Date of first enrolment	01/05/2002
Date of final enrolment	01/04/2003

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

John Radcliffe Hospital

Oxford
OX3 9DU
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	27/01/2004		Yes	No