Contact information
Type
Scientific
Primary contact
Prof Cor J Kalkman
ORCID ID
Contact details
University Medical Centre Utrecht
Dept of Anesthesiology
Heidelbergln 100
Utrecht
3584 CX
Netherlands
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c.j.kalkman@azu.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Long-term cognitive decline after coronary artery bypass grafting: is off-pump surgery beneficial?
Acronym
Octopus Study
Study hypothesis
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Coronary artery disease
Intervention
Random allocation to on-pump or off-pump coronary artery bypass grafting
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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 individuals 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 individuals performance of at least 20 percent from baseline, in at least 20 percent of the tests.
Secondary outcome measures
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)
Overall trial start date
01/01/1998
Overall trial end date
31/12/2000
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
281
Participant exclusion criteria
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.
Recruitment start date
01/01/1998
Recruitment end date
31/12/2000
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Centre Utrecht
Utrecht
3584 CX
Netherlands
Sponsor information
Organisation
International Anesthesia Research Society (USA)
Sponsor details
2 Summit Park Drive
Suite 140
Cleveland
Ohio 44131
United States of America
-
iarshq@iars.org
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
International Anesthesia Research Society
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Clinical scholar research award 2004
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
Basic results (scientific)
Publication list
1. 2007 results: http://www.ncbi.nlm.nih.gov/pubmed/17312289
2. 2004 results: https://www.ncbi.nlm.nih.gov/pubmed/15020522
3. 2003 results: https://www.ncbi.nlm.nih.gov/pubmed/12556542
4. 2002 results: https://www.ncbi.nlm.nih.gov/pubmed/11903027
5. 2001 results: https://www.ncbi.nlm.nih.gov/pubmed/11591611
6. 2000 rationale and design of the trial: https://www.ncbi.nlm.nih.gov/pubmed/11146152
Publication citations
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Results
Nathoe HM, van Dijk D, Jansen EW, Suyker WJ, Diephuis JC, van Boven WJ, de la Rivière AB, Borst C, Kalkman CJ, Grobbee DE, Buskens E, de Jaegere PP, , A comparison of on-pump and off-pump coronary bypass surgery in low-risk patients., N. Engl. J. Med., 2003, 348, 5, 394-402, doi: 10.1056/NEJMoa021775.
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Rationale and design of the trial
van Dijk D, Nierich AP, Eefting FD, Buskens E, Nathoe HM, Jansen EW, Borst C, Knape JT, Bredée JJ, Robles de Medina EO, Grobbee DE, Diephuis JC, de Jaegere PP, The Octopus Study: rationale and design of two randomized trials on medical effectiveness, safety, and cost-effectiveness of bypass surgery on the beating heart., Control Clin Trials, 2000, 21, 6, 595-609.
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van Dijk D, Spoor M, Hijman R, Nathoe HM, Borst C, Jansen EW, Grobbee DE, de Jaegere PP, Kalkman CJ, , Cognitive and cardiac outcomes 5 years after off-pump vs on-pump coronary artery bypass graft surgery., JAMA, 2007, 297, 7, 701-708, doi: 10.1001/jama.297.7.701.
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van Dijk D, Moons KG, Keizer AM, Jansen EW, Hijman R, Diephuis JC, Borst C, de Jaegere PP, Grobbee DE, Kalkman CJ, , Association between early and three month cognitive outcome after off-pump and on-pump coronary bypass surgery., Heart, 2004, 90, 4, 431-434.
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Van Dijk D, Jansen EW, Hijman R, Nierich AP, Diephuis JC, Moons KG, Lahpor JR, Borst C, Keizer AM, Nathoe HM, Grobbee DE, De Jaegere PP, Kalkman CJ, , Cognitive outcome after off-pump and on-pump coronary artery bypass graft surgery: a randomized trial., JAMA, 2002, 287, 11, 1405-1412.
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van Dijk D, Nierich AP, Jansen EW, Nathoe HM, Suyker WJ, Diephuis JC, van Boven WJ, Borst C, Buskens E, Grobbee DE, Robles De Medina EO, de Jaegere PP, , Early outcome after off-pump versus on-pump coronary bypass surgery: results from a randomized study., Circulation, 2001, 104, 15, 1761-1766.