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NCT00953368 Clinical Trial

Effect of Remote Ischemic Preconditioning on Cognitive Function After Off-Pump Coronary Artery Bypass Graft

Ischemic Heart Disease Clinical Trial

Official title:
Effect of Remote Ischemic Preconditioning on Cognitive Function After Off-Pump Coronary Artery Bypass Graft

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00953368
Other study ID # RIPC-3862
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received August 5, 2009
Last updated August 5, 2009
Start date October 2009
Est. completion date March 2012

Study information
Verified date August 2009
Source Asan Medical Center
Contact In-Cheol Choi, professor
Phone +82-2-3010-3862
Email icchoi@amc.seoul.kr
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 270
Est. completion date March 2012
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Procedure:
• remote ischemic preconditioning
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

Locations
Country Name City State
Korea, Republic of Department of Anesthesiology and Pain Medicine, University of Ulsan, College of Medicine, Asan Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary cognitive function preoperative, 1 week and 6 months after surgery No
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