Long-Term Cognitive Decline After Coronary Artery Bypass Grafting: is Off-Pump Surgery Beneficial?
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- UMC Utrecht
- Enrollment
- 280
- Locations
- 2
- Primary Endpoint
- cognitive decline 5 year after the index treatment
Study Overview
Brief Summary
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.
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
cognitive decline 5 year after the index treatment
Secondary Outcomes
- -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