- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00189215
Long-Term Cognitive Decline After Coronary Artery Bypass Grafting: is Off-Pump Surgery Beneficial?
Study Overview
Status
Intervention / Treatment
Detailed Description
Background:
Coronary artery bypass surgery is associated with postoperative cognitive decline, which has largely been attributed to the use of cardiopulmonary bypass (CPB). A large recent study by Newman et al demonstrated that the incidence of cognitive decline was 24% at six months after surgery, but it increased to 42% at five years. In the recently conducted Octopus Randomized Trial, cognitive decline at three months after surgery was present in 29% of the patients operated with CPB. In the patients operated without CPB, the incidence was 21%, i.e. only slightly better.
Hypothesis:
Improvement of cognitive outcome by avoiding cardiopulmonary bypass will become more apparent five years after surgery, compared to three months after surgery.
Study objectives:
The objective of the present study is to compare the effect of coronary bypass surgery with and without cardiopulmonary bypass on cognitive and clinical outcome, five years after surgery.
Methods:
The 281 participants of the Octopus Study, who were operated on between March 1998 and August 2000 and randomized to off-pump or on-pump coronary bypass surgery, will be invited for an additional assessment of their cognitive and clinical status and quality of life, five years after surgery. Patients will undergo a battery of ten neuropsychologic tests to determine their cognitive status. Clinical status will be assessed by an interview. Questionnaires will be used to measure quality of life.
Study Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
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Utrecht, Netherlands, 3584 CX
- University Medical Center, Department of Anesthesiology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- indication for (first-time) coronary artery bypass surgery
- off-pump CABG considered technically possible
Exclusion Criteria:
- concomitant valve surgery
- unable to complete neuropsychological testing
- life expectancy less than 1 year
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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cognitive decline 5 year after the index treatment
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Secondary Outcome Measures
Outcome Measure |
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-freedom from cardiovascular events (i.e. mortality, stroke, myocardial infarction, re-CABG, or PTCA
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-recurrence of angina
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-use of anti-anginal drugs
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-quality of life (SF-36 and EuroQuol
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Cor J Kalkman, MD, PhD, UMC Utrecht, The Netherlands
Publications and helpful links
General Publications
- van Dijk D, Nierich AP, Eefting FD, Buskens E, Nathoe HM, Jansen EW, Borst C, Knape JT, Bredee 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 Dec;21(6):595-609. doi: 10.1016/s0197-2456(00)00103-3.
- 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; Octopus Study Group. Cognitive outcome after off-pump and on-pump coronary artery bypass graft surgery: a randomized trial. JAMA. 2002 Mar 20;287(11):1405-12. doi: 10.1001/jama.287.11.1405.
- Nathoe HM, van Dijk D, Jansen EW, Suyker WJ, Diephuis JC, van Boven WJ, de la Riviere AB, Borst C, Kalkman CJ, Grobbee DE, Buskens E, de Jaegere PP; Octopus Study Group. A comparison of on-pump and off-pump coronary bypass surgery in low-risk patients. N Engl J Med. 2003 Jan 30;348(5):394-402. doi: 10.1056/NEJMoa021775.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WOM protocol 98/009-O
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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