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ISRCTN
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ISRCTN69438133
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ClinicalTrials.gov identifier
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Public title
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Long-term cognitive decline after coronary artery bypass grafting: is off-pump surgery beneficial?
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Scientific title
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Acronym
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Octopus Study
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Serial number at source
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N/A
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Study hypothesis
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The aim of the present study is to compare the effect of coronary bypass surgery with and without cardiopulmonary bypass on cognitive outcome, five years after surgery.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Coronary artery disease
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Participants - inclusion criteria
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281 candidates for coronary artery bypass surgery. Patients were eligible if referred for first-time isolated coronary bypass surgery and an off-pump procedure was deemed technically feasible.
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Participants - exclusion criteria
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1. Patients were excluded in case of emergency or concomitant major surgery, Q-wave myocardial infarction in the last 6 weeks, or poor left ventricular function.
2. Patients who were unlikely to complete 1-year follow-up, unable to give informed consent, or undergo neuropsychologic testing were excluded.
3. There were no restrictions to age.
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Anticipated start date
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01/01/1998
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Anticipated end date
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31/12/2000
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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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281
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Interventions
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Random allocation to on-pump or off-pump coronary artery bypass grafting
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Primary outcome measure(s)
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The primary endpoint of the present study is cognitive outcome at five years after surgery. Patients will undergo a battery of ten neuropsychologic tests five years after operation. The tests will be administered by a trained psychologist blinded for treatment allocation. Each individual’s performance on the neuropsychologic tests will be compared to his or her performance on the same tests five years earlier, on the day before operation. In accordance to the Statement of Consensus on Assessment of Neurobehavioral Outcomes after Cardiac Surgery the test battery includes tests for motor skills, verbal memory capacity and attention. The principal outcome measure is cognitive decline, defined as a decrease in an individual’s performance of at least 20 percent from baseline, in at least 20 percent of the tests.
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Secondary outcome measure(s)
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1. Quality of life at five years, assessed with the EuroQol10 and ShortForm-3611 questionnaires
2. The occurence of cardiovascular events i.e. mortality, stroke, myocardial infarction and coronary reintervention. Stroke is defined as focal brain injury, detected by standard neurologic examination, persisting for more than 24 hours, combined with an increase in handicap of at least one grade on the Rankin Scale; Myocardial infarction is considered present when two of the following criteria are met: chest discomfort lasting at least 30 minutes, CK-MB/CK ratio >0.1, and the development of abnormal new Q-waves in the electrocardiogram.
3. Anginal status at five years, defined according to the Canadian Cardiovascular Society and Braunwald classification
4. Use of antianginal medication at five years (Beta-blockers, nitrates or calcium entry-blockers)
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Sources of funding
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International Anesthesia Research Society
Clinical scholar research award 2004
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Trial website
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Publications
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1. 2007 results: http://www.ncbi.nlm.nih.gov/pubmed/17312289
2. 2004 results: http://www.ncbi.nlm.nih.gov/pubmed/15020522
3. 2003 results: http://www.ncbi.nlm.nih.gov/pubmed/12556542
4. 2002 results: http://www.ncbi.nlm.nih.gov/pubmed/11903027
5. 2001 results: http://www.ncbi.nlm.nih.gov/pubmed/11591611
6. Rationale and design of the trial: http://www.ncbi.nlm.nih.gov/pubmed/11146152
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Contact name
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Prof
Cor J
Kalkman
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Address
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University Medical Centre Utrecht
Dept of Anesthesiology
Heidelbergln 100
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City/town
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Utrecht
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Zip/Postcode
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3584 CX
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Country
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Netherlands
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Email
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c.j.kalkman@azu.nl
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Sponsor
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International Anesthesia Research Society (USA)
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Address
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2 Summit Park Drive, Suite 140
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City/town
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Cleveland
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Zip/Postcode
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Ohio 44131
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Country
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United States of America
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Email
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iarshq@iars.org
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Date applied
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24/04/2005
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Last edited
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08/05/2008
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Date ISRCTN assigned
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19/09/2005
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