The Effect of Remote Ischemic Preconditioning on Major Organ Function in Patients With Coronary Artery Disease Undergoing Orthopedic Surgery (RIPC-Angina)

Seoul National University

Status: Completed

Conditions: Angina Pectoris; Myocardial Infarction

Treatments: Procedure: Remote ischemic preconditioning; Procedure: Sham control

Study type: Interventional

Funder types: Other

Identifiers

NCT02808936

1604-079-754

Details and patient eligibility

About

The investigators attempt to investigate the organ protective effect of remote ischemic conditioning in patients undergoing non-cardiac surgery with history of ischemic heart disease.

Full description

When adult patients with ischemic heart disease undergo non-cardiac surgery, perioperative ischemic complication may occur. These morbidity results in poor clinical outcomes. The incidence of perioperative myocardial ischemic event has been reported to be up to 19.7%. Remote ischemic preconditioning (RIPC) is a concept that a brief ischemic reperfusion of upper or lower extremity can transfer protection to the other vital organs from sustained ischemic reperfusion injury. Although RIPC is extensively studied in high risk cardiovascular surgery, it has not been tested in a non-cardiac surgery patients with a history of ischemic heart disease. Major organ injury including heart, lung and kidney will be evaluated in this randomized controlled trial.

Enrollment: 60 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults patients who undergo orthopedic surgery with duration of longer than one hour
• Patients with a history of ischemic heart disease (stable or unstable angina, myocardial infarction)
• American Society of Anesthesiology (ASA) Physical Status Classification of 1, 2, or 3

Exclusion criteria

• Peripheral vascular disease involving upper or lower extremity
• Orthopedic surgery which uses the tourniquet

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

RIPC group

Experimental group

Description:

remote ischemic conditioning group with three cycles of ischemia (5 min) / reperfusion (5 min) of upper or lower limb available with automated RIPC machine using blood pressure cuff

Treatment:

Procedure: Remote ischemic preconditioning

Control group

Sham Comparator group

Description:

No remote ischemic conditioning, but blood pressure cuff applied to the upper or lower limb available

Treatment:

Procedure: Sham control