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

NCT ID: NCT00953368

Last Updated: 2009-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ischemic Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

remote ischemic preconditioning

Intervention Type PROCEDURE

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

control

sham placement of a blood-pressure cuff around the upper limb without inflation

Group Type PLACEBO_COMPARATOR

remote ischemic preconditioning

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Asan Medical Center, Department of Anesthesiology and Pain Medicine

Principal Investigators

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In-Cheol Choi, professor

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center, Department of Anesthesiology and Pain Medicine

Locations

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Department of Anesthesiology and Pain Medicine, University of Ulsan, College of Medicine, Asan Medical Center

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Central Contacts

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In-Cheol Choi, professor

Role: CONTACT

+82-2-3010-3862

Dae-Kee Choi, fellow

Role: CONTACT

+82-2-3010-5633

Facility Contacts

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In-Cheol Choi, professor

Role: primary

+82-2-3010-3862

Dae-Kee Choi, fellow

Role: backup

+82-2-3010-5633

References

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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.

Reference Type BACKGROUND
PMID: 11903027 (View on PubMed)

Other Identifiers

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RIPC-3862

Identifier Type: -

Identifier Source: org_study_id

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