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
| ISRCTN | ISRCTN20472718 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20472718 |
| Secondary identifying numbers | 066216 |
- Submission date
- 22/07/2005
- Registration date
- 22/07/2005
- Last edited
- 12/06/2015
- 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
Mr Joseph Brindaban Selvanayagam
Scientific
Scientific
John Radcliffe Hospital
MRS Building
University of Oxford Clinical Magnetic Resonance Research Centre
Headley Way
Oxford
OX3 9DU
United Kingdom
| Phone | +44 (0)1865 221867 |
|---|---|
| joseph.selvanayagam@cardiov.ox.ac.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 | 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 |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | CABG surgery |
| Intervention | Single centre randomised trial comparing off pump (beating heart) versus conventional bypass coronary artery surgery. |
| Intervention type | Procedure/Surgery |
| 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 study start date | 01/05/2002 |
| Completion date | 01/10/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 50 |
| Key inclusion criteria | 1. Aged less than 75 years 2. Isolated coronary grafting |
| Key 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) |
| Date of first enrolment | 01/05/2002 |
| Date of final enrolment | 01/04/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
OX3 9DU
United Kingdom
Sponsor information
University of Oxford (UK)
University/education
University/education
University Offices
Wellington Square
Oxford
OX1 2JD
England
United Kingdom
| Phone | +44 (0)1865 270143 |
|---|---|
| research.services@admin.ox.ac.uk | |
| Website | http://www.ox.ac.uk |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Charity
Wellcome Trust (UK) (grant ref: 066216)
Private sector organisation / International organizations
Private sector organisation / International organizations
- 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 | 27/01/2004 | Yes | No |
