A randomised trial of on pump beating heart surgery and blood cardioplegia in patients with impaired left ventricular function using cardiac magnetic resonance imaging and biochemical markers

ISRCTN	ISRCTN41388968
DOI	https://doi.org/10.1186/ISRCTN41388968
Protocol serial number	COREC 05/Q1603/42
Sponsor	Oxford Radcliffe Hospitals NHS Trust (UK)
Funder	British Heart Foundation (BHF) (UK) (ref: PG/05/037)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof David Taggart
Scientific

Department of Cardiothoracic Surgery
John Radcliffe Hospital
Headington
Oxford
OX3 9DU
United Kingdom

Phone	+44 (0)1856 221121
Email	david.taggart@orh.nhs.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Beating heart surgery in patients with poor ventricular function leads to improved early end systolic volume index as measured by cardiac magnetic resonance imaging (MRI).
Ethics approval(s)	Ethics approval received from Central Office for Research Ethics Committees (COREC) (ref: 05/Q1603/42)
Health condition(s) or problem(s) studied	Ischaemic heart disease
Intervention	The trial involves comparing standard on pump warm blood cardioplegia coronary artery bypass grafting to a modified surgical technique where the patient undergoes beating heart surgery but is maintained on cardiopulmonary bypass to decompress the left ventricle.
Intervention type	Other
Primary outcome measure(s)	1. End systolic volume index 2. End diastolic volume index
Key secondary outcome measure(s)	1. Hospital stay 2. Mortality 3. Creatine kinase myocardial bands (CKMB) 4. Troponin 5. Ventilation 6. Dialysis 7. Intra-aortic balloon pump (IABP) duration 8. Peak creatinine
Completion date	01/11/2007

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	50
Key inclusion criteria	1. Ejection fraction less than 30% 2. Creatinine less than 170 μmol/l
Key exclusion criteria	1. Contra-indications to MRI scanning 2. Claustrophobia
Date of first enrolment	01/11/2005
Date of final enrolment	01/11/2007

Department of Cardiothoracic Surgery

Oxford
OX3 9DU
United Kingdom

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	18/11/2008		Yes	No
Results article	results	01/05/2011		Yes	No