Effect of Remote Ischemic Preconditioning on Cognitive Function After Off-Pump Coronary Artery Bypass Graft
1 other identifier
interventional
270
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2009
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2009
CompletedFirst Posted
Study publicly available on registry
August 6, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedAugust 6, 2009
August 1, 2009
2.4 years
August 5, 2009
August 5, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
cognitive function
preoperative, 1 week and 6 months after surgery
Study Arms (2)
Remote ischemic preconditioning
ACTIVE COMPARATORRemote 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
control
PLACEBO COMPARATORsham placement of a blood-pressure cuff around the upper limb without inflation
Interventions
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
Eligibility Criteria
You may qualify if:
- Patients undergoing elective off-pump coronary artery bypass graft surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology and Pain Medicine, University of Ulsan, College of Medicine, Asan Medical Center
Seoul, Seoul, 138-736, South Korea
Related Publications (1)
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.
PMID: 11903027BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
In-Cheol Choi, professor
Asan Medical Center, Department of Anesthesiology and Pain Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 5, 2009
First Posted
August 6, 2009
Study Start
October 1, 2009
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
August 6, 2009
Record last verified: 2009-08