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

Asan Medical Center

Status and phase: Unknown; Phase 1

Conditions: Ischemic Heart Disease

Treatments: Procedure: remote ischemic preconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT00953368

RIPC-3862

Details and patient eligibility

About

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.

Enrollment: 270 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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270 participants in 2 patient groups, including a placebo group

Remote ischemic preconditioning

Active Comparator group

Description:

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

Treatment:

Procedure: remote ischemic preconditioning

control

Placebo Comparator group

Description:

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

Treatment:

Procedure: remote ischemic preconditioning