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

Seoul National University logo

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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