NCT00953368UnknownPhase 1
Effect of Remote Ischemic Preconditioning on Cognitive Function After Off-Pump Coronary Artery Bypass Graft
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Asan Medical Center
- Enrollment
- 270
- Locations
- 1
- Primary Endpoint
- cognitive function
Study Overview
Brief Summary
The aim of this study is to evaluate the effects of remote ischemic preconditioning on cognitive function in patients undergoing off-pump coronary artery bypass graft.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients undergoing elective off-pump coronary artery bypass graft surgery
Exclusion Criteria
- •Emergency operation
- •Preoperative use of inotropic drugs or mechanical assistant device
- •Ejection fraction less than 30%
- •Combined operation using CPB such as valve surgery
- •Previous psychiatric and neurologic disorder
- •Inability to perform the cognitive function test
Arms & Interventions
Remote ischemic preconditioning
Active Comparator
Remote ischemic preconditioning will be induced by four 5-min cycles of upper limb ischemia and 5-min reperfusion with a blood-pressure cuff inflated to 200 mmHg and be performed before and after the coronary anastomosis
Intervention: remote ischemic preconditioning (Procedure)
control
Placebo Comparator
sham placement of a blood-pressure cuff around the upper limb without inflation
Intervention: remote ischemic preconditioning (Procedure)
Outcomes
Primary Outcomes
cognitive function
Time Frame: preoperative, 1 week and 6 months after surgery
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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