Long-Term Cognitive Decline After Coronary Artery Bypass Grafting: is Off-Pump Surgery Beneficial?
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|ClinicalTrials.gov Identifier: NCT00189215|
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : December 4, 2007
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Cardiopulmonary Bypass Cognition Disorders||Device: cardiac stabilizer instead of cardiopulmonary bypass||Phase 4|
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.
Improvement of cognitive outcome by avoiding cardiopulmonary bypass will become more apparent five years after surgery, compared to three months after surgery.
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.
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||280 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Long-Term Cognitive Decline After Coronary Artery Bypass Grafting: is Off-Pump Surgery Beneficial?|
|Study Start Date :||March 1998|
|Estimated Study Completion Date :||December 2005|
- cognitive decline 5 year after the index treatment
- -freedom from cardiovascular events (i.e. mortality, stroke, myocardial infarction, re-CABG, or PTCA
- -recurrence of angina
- -use of anti-anginal drugs
- -quality of life (SF-36 and EuroQuol
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00189215
|University Medical Center, Department of Anesthesiology|
|Utrecht, Netherlands, 3584 CX|
|Study Director:||Cor J Kalkman, MD, PhD||UMC Utrecht, The Netherlands|