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ISRCTN
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ISRCTN97967360
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ClinicalTrials.gov identifier
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Public title
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Randomised study of neurocognitive outcome and cerebral embolic events in patients undergoing off-pump and on-pump coronary artery bypass graft surgery
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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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
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Lay summary
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Ethics approval
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Wandsworth Local Research Ethics Committee (ref: 01.78.6, R+D Number 00.2431), in October 2001.
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Neurocognitive dysfunction
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Participants - inclusion criteria
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Patients undergoing first time elective coronary artery bypass surgery.
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Participants - exclusion criteria
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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
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Anticipated start date
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01/08/2002
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Anticipated end date
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01/03/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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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.
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Primary outcome measure(s)
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Post-operative composite neurocognitive score at six months and three years.
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Secondary outcome measure(s)
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The neurocognitive score at discharge and at six weeks, and the total intra-operative microemboli count.
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Sources of funding
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1. St George's Hospital Cardiothoracic Research Fund
2. The Royal College of Surgeons of England
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Trial website
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Publications
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http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=15019669
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=16863773
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Contact name
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Miss
Marjan
Jahangiri
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Address
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Department of Cardiac Surgery
Atkinson Morley Wing
St George's Hospital & Medical School
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City/town
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London
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Zip/Postcode
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SW17 0QT
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Country
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United Kingdom
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Sponsor
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St George's Hospital (UK)
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Address
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Blackshaw Road
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City/town
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London
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Zip/Postcode
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SW17 0QT
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Country
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United Kingdom
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Date applied
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19/09/2004
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Last edited
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17/08/2006
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Date ISRCTN assigned
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22/10/2004
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