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
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Miss Marjan Jahangiri
Scientific

Department of Cardiac Surgery
Atkinson Morley Wing
St George's Hospital & Medical School
London
SW17 0QT
United Kingdom

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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	Post-operative composite neurocognitive score at six months and three years.
Secondary outcome measures	The neurocognitive score at discharge and at six weeks, and the total intra-operative microemboli count.
Overall study start date	01/08/2002
Completion date	01/03/2004

Participant type(s)	Patient
Age group	Not Specified
Sex	Both
Target number of participants	Not provided at time of registration
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

St George's Hospital

Department of Cardiac Surgery
Blackshaw Road
London
SW17 0QT
United Kingdom

St George's Hospital (UK)
Not defined

Blackshaw Road
London
SW17 0QT
United Kingdom

"ROR"	https://ror.org/0001ke483

Research organisation

St George's Hospital Cardiothoracic Research Fund

No information available

The Royal College of Surgeons of England

No information available

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

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

27/11/2015: Publication reference added.