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
Secondary identifying numbers	COREC 05/Q1603/42

Submission date: 24/10/2005
Registration date: 03/02/2006
Last edited: 04/07/2011

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

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

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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	1. End systolic volume index 2. End diastolic volume index
Secondary outcome measures	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
Overall study start date	01/11/2005
Completion date	01/11/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	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

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Cardiothoracic Surgery

Oxford
OX3 9DU
United Kingdom

Sponsor information

Oxford Radcliffe Hospitals NHS Trust (UK)
Hospital/treatment centre

Ian Goodall
Research and Development Office
Oxford Radcliffe Hospitals NHS Trust
John Radciffe Hospital
Headington
Oxford
OX3 9DZ
England
United Kingdom

Phone	+44 (0)1865 222757
Email	ian.goodall@orh.nhs.uk
"ROR"	https://ror.org/03h2bh287

Funders

Funder type

Charity

British Heart Foundation (BHF) (UK) (ref: PG/05/037)
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): the_bhf, The British Heart Foundation, BHF
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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	18/11/2008		Yes	No
Results article	results	01/05/2011		Yes	No