Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
30/08/2013
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 P Taggart

ORCID ID

Contact details

Department of Cardiovascular Medicine
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
+44 (0)1865 222086
david.taggart@orh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0176113611

Study information

Scientific title

Acronym

Study hypothesis

1. To quantify both functional and irreversible myocardial injury after CABG, with and without cardiopulmonary bypass (CPB) using multiparametric cardiac MRI at the highest spatial resolution.
2. To quantify the pathophysiological significance of bio chemically defined myocardial injury with MRI determined grams of myocardial tissue loss after CABG, with and without CPB.
3. To define the power of these new MRI indices to predict functional recovery at 6 months post-surgical revascularisation.

Ethics approval

Not provided at time of registration

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

Surgery: Coronary artery bypass grafting (CABG)

Intervention

Patients will be randomised to receive conventional CABG or off-pump CABG (OPCABG).

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

1. Number and percentage of new left ventricular (LV) wall segments that are assessed as non viable by late Gd-DTPA MR imaging in both the conventional CABG and OPCABG groups
2. The distribution (regional versus global) of new non viable LV segments in both the conventional CABG and OPCABG groups
3. The extent of post operative rise in biochemical cardiac markers will be compared in the two surgical groups and will be correlated with the functional cardiac MR assessment.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/2002

Overall trial end date

30/09/2003

Reason abandoned

Eligibility

Participant inclusion criteria

90 patients undergoing CABG

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

90 (70 study patients and 20 post MI patients)

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/06/2002

Recruitment end date

30/09/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Cardiovascular Medicine
Oxford
OX3 9DU
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Oxford Radcliffe Hospitals NHS Trust (UK) - Departmental resources

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2004 results in: http://www.ncbi.nlm.nih.gov/pubmed/14732755

Publication citations

  1. Results

    Selvanayagam JB, Petersen SE, Francis JM, Robson MD, Kardos A, Neubauer S, Taggart DP, Effects of off-pump versus on-pump coronary surgery on reversible and irreversible myocardial injury: a randomized trial using cardiovascular magnetic resonance imaging and biochemical markers., Circulation, 2004, 109, 3, 345-350, doi: 10.1161/01.CIR.0000109489.71945.BD.

Additional files

Editorial Notes