Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Randomised study of neurocognitive outcome and cerebral embolic events in patients undergoing off-pump and on-pump coronary artery bypass graft surgery
Acronym
Study hypothesis
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
Wandsworth Local Research Ethics Committee (ref: 01.78.6, R+D Number 00.2431), in October 2001.
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
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/08/2002
Overall trial end date
01/03/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Patients undergoing first time elective coronary artery bypass surgery.
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
Not provided at time of registration
Participant 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
Recruitment start date
01/08/2002
Recruitment end date
01/03/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St George's Hospital
Department of Cardiac Surgery
Blackshaw Road
London
SW17 0QT
United Kingdom
Funders
Funder type
Research organisation
Funder name
St George's Hospital Cardiothoracic Research Fund
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Royal College of Surgeons of England
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/15019669
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16863773
Publication citations
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Motallebzadeh R, Kanagasabay R, Bland M, Kaski JC, Jahangiri M, S100 protein and its relation to cerebral microemboli in on-pump and off-pump coronary artery bypass surgery., Eur J Cardiothorac Surg, 2004, 25, 3, 409-414, doi: 10.1016/j.ejcts.2003.12.018.
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Motallebzadeh R, Bland JM, Markus HS, Kaski JC, Jahangiri M, Health-related quality of life outcome after on-pump versus off-pump coronary artery bypass graft surgery: a prospective randomized study., Ann. Thorac. Surg., 2006, 82, 2, 615-619, doi: 10.1016/j.athoracsur.2006.03.081.