A Phase 4 interventional study of cardiac stabilizer instead of cardiopulmonary bypass in Coronary Artery Disease, Cardiopulmonary Bypass and Cognition Disorders, sponsored by UMC Utrecht. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-12-04.
Sponsored by UMC Utrecht · Phase 4, Interventional, and Prevention
Coronary artery bypass surgery is associated with postoperative cognitive decline, which has largely been attributed to the use of the heart lung machine. We hypothesized that long-term cognitive outcome may improve by avoiding the heart lung machine. The objective of the present study is to compare the effect of coronary bypass surgery with and without heart lung machine on cognitive and clinical outcome, five years after surgery.
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.
5,676 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.
This study's enrollment of 280 is above the median of 123 across 3,481 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →UMC Utrecht is the lead sponsor of 363 studies on the registry; 81 are open to participants now.
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Exclusion Criteria:
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
The record gives a start of Mar 1998 and a completion of Dec 2005. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2005. You cannot join it, but the record below documents what was studied.
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