Randomised study of neurocognitive outcome and cerebral embolic events in patients undergoing off-pump and on-pump coronary artery bypass graft surgery
| ISRCTN | ISRCTN97967360 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97967360 |
| Protocol serial number | N/A |
| Sponsor | St George's Hospital (UK) |
| Funders | St George's Hospital Cardiothoracic Research Fund, The Royal College of Surgeons of England |
- Submission date
- 19/09/2004
- Registration date
- 22/10/2004
- Last edited
- 27/11/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Miss Marjan Jahangiri
Scientific
Scientific
Department of Cardiac Surgery
Atkinson Morley Wing
St George's Hospital & Medical School
London
SW17 0QT
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Randomised study of neurocognitive outcome and cerebral embolic events in patients undergoing off-pump and on-pump coronary artery bypass graft surgery |
| Study objectives | 1. Cerebral injury, determined by neuropsychological testing, is reduced in off-pump compared with on-pump patients 2. Perioperative embolisation is reduced in off-pump, compared with on-pump, surgery 3. Any reduction in cerebral injury is mediated by a reduction in perioperative embolisation |
| Ethics approval(s) | Wandsworth Local Research Ethics Committee (ref: 01.78.6, R+D Number 00.2431), in October 2001. |
| Health condition(s) or problem(s) studied | Neurocognitive dysfunction |
| Intervention | Patients are divided into two groups: those undergoing on-pump and those having off-pump coronary artery surgery. Comparisons between intraoperative cerebral embolic burden and postoperative neurocognitive function are made between the two groups. |
| Intervention type | Other |
| Primary outcome measure(s) |
Post-operative composite neurocognitive score at six months and three years. |
| Key secondary outcome measure(s) |
The neurocognitive score at discharge and at six weeks, and the total intra-operative microemboli count. |
| Completion date | 01/03/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Key inclusion criteria | Patients undergoing first time elective coronary artery bypass surgery. |
| Key exclusion criteria | 1. Previous cerebrovascular accident or Transient Ischaemic Attack (TIA) 2. Right or left internal carotid artery stenosis more than or equal to 50% 3. Previous cardiac surgery 4. Concomitant surgery, e.g. valve replacement 5. Previous psychiatric illness, e.g. depression, schizophrenia 6. Dialysis-dependent renal failure 7. Q-wave myocardial infarction in the past six weeks 8. Very poor left ventricular function (ejection fraction less than 20%) 9. Illiteracy or non-fluency in English 10. Absence of an acoustic window for transcranial Doppler ultrasound monitoring |
| Date of first enrolment | 01/08/2002 |
| Date of final enrolment | 01/03/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
St George's Hospital
Department of Cardiac Surgery
Blackshaw Road
London
SW17 0QT
United Kingdom
Blackshaw Road
London
SW17 0QT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 01/03/2004 | Yes | No | |
| Results article | results | 01/08/2006 | Yes | No |
Editorial Notes
27/11/2015: Publication reference added.
