Condition category
Circulatory System
Date applied
24/10/2005
Date assigned
03/02/2006
Last edited
04/07/2011
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

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 measures

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

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

foundation

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. 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

  1. 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.

  2. 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.

Additional files

Editorial Notes