Contact information
Type
Scientific
Primary contact
Mr Joseph Brindaban Selvanayagam
ORCID ID
Contact details
John Radcliffe Hospital
MRS Building
University of Oxford Clinical Magnetic Resonance Research Centre
Headley Way
Oxford
OX3 9DU
United Kingdom
+44 (0)1865 221867
joseph.selvanayagam@cardiov.ox.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
066216
Study information
Scientific title
Effects of off pump versus on pump coronary surgery on reversible and irreversible myocardial injury: a randomised trial using cardiovascular magnetic resonance imaging and biochemical markers
Acronym
Study hypothesis
Using Cardiovascular Magnetic Resonance imaging (CMR), we compared the extent of peri-operative myocardial reversible injury (myocardial stunning) and irreversible injury (myocardial necrosis) in patients undergoing multi-vessel Coronary Artery Bypass Graft surgery (CABG) with and without cardiopulmonary bypass, in a single center randomised trial.
To our knowledge, this is the first such study using cine and contrast-enhanced CMR. Furthermore, we correlated these CMR findings with the changes in post operative cardiac Troponin I. Our primary hypothesis was that off pump surgery results in reduced myocardial stunning (as measured by cine MRI) in the early post-operative period when compared to ON-pump CABG (ONCABG) surgery. We further hypothesised that off pump surgery is superior to ONCABG with regards to the extent of permanent myocardial damage and that post-operative myocardial enzyme release reflects myonecrosis.
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
CABG surgery
Intervention
Single centre randomised trial comparing off pump (beating heart) versus conventional bypass coronary artery surgery.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
1. Left ventricular function at one week post-op
2. LV function at six months post-op
3. Myocardial necrosis post-op
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/05/2002
Overall trial end date
01/10/2003
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged less than 75 years
2. Isolated coronary grafting
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant exclusion criteria
1. Age greater than 75 years (ten patients)
2. Ppre-existing Left Ventricular (LV) dysfunction (ejection fraction less than 20% by echocardiogram; four patients)
3. Involvement in other clinical trials (ten patients)
4. Typical MRI contraindications (e.g. pacemaker, severe claustrophobia etc.; total of nine patients)
5. Baseline creatinine more than 200 µmol/L (two patients)
Recruitment start date
01/05/2002
Recruitment end date
01/04/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
Sponsor information
Organisation
University of Oxford (UK)
Sponsor details
University Offices
Wellington Square
Oxford
OX1 2JD
United Kingdom
+44 (0)1865 270143
research.services@admin.ox.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Wellcome Trust (UK) (grant ref: 066216)
Alternative name(s)
Wellcome
Funding Body Type
private sector organisation
Funding Body Subtype
international
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. 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/14732755
Publication citations
-
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.