Contact information
Type
Scientific
Primary contact
Prof David Taggart
ORCID ID
Contact details
Department of Cardiothoracic Surgery
John Radcliffe Hospital
Headington
Oxford
OX3 9DU
United Kingdom
+44 (0)1856 221121
david.taggart@orh.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
COREC 05/Q1603/42
Study information
Scientific title
Acronym
Study hypothesis
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
Ethics approval received from Central Office for Research Ethics Committees (COREC) (ref: 05/Q1603/42)
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
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
Phase
Not Specified
Drug names
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 trial start date
01/11/2005
Overall trial end date
01/11/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Ejection fraction less than 30%
2. Creatinine less than 170 μmol/l
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant exclusion criteria
1. Contra-indications to MRI scanning
2. Claustrophobia
Recruitment start date
01/11/2005
Recruitment end date
01/11/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Cardiothoracic Surgery
Oxford
OX3 9DU
United Kingdom
Sponsor information
Organisation
Oxford Radcliffe Hospitals NHS Trust (UK)
Sponsor details
Ian Goodall
Research and Development Office
Oxford Radcliffe Hospitals NHS Trust
John Radciffe Hospital
Headington
Oxford
OX3 9DZ
United Kingdom
+44 (0)1865 222757
ian.goodall@orh.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
British Heart Foundation (BHF) (UK) (ref: PG/05/037)
Alternative name(s)
BHF
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
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
Basic results (scientific)
Publication list
1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18981306
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21378388
Publication citations
-
Results
Pegg TJ, Selvanayagam JB, Francis JM, Karamitsos TD, Maunsell Z, Yu LM, Neubauer S, Taggart DP, A randomized trial of on-pump beating heart and conventional cardioplegic arrest in coronary artery bypass surgery patients with impaired left ventricular function using cardiac magnetic resonance imaging and biochemical markers., Circulation, 2008, 118, 21, 2130-2138, doi: 10.1161/CIRCULATIONAHA.108.785105.
-
Results
Pegg TJ, Maunsell Z, Karamitsos TD, Taylor RP, James T, Francis JM, Taggart DP, White H, Neubauer S, Selvanayagam JB, Utility of cardiac biomarkers for the diagnosis of type V myocardial infarction after coronary artery bypass grafting: insights from serial cardiac MRI., Heart, 2011, 97, 10, 810-816, doi: 10.1136/hrt.2010.213462.