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Effect of Remote Preconditioning in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery

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Seoul National University

Status and phase

Completed
Phase 1

Conditions

Ischemic Heart Disease

Treatments

Procedure: remote ischemic preconditioning

Study type

Interventional

Funder types

Other

Identifiers

NCT00889811
H-0806-060-247

Details and patient eligibility

About

In recent several clinical trials, remote preconditioning showed very powerful myocardial protection. However, the myocardial protective effect by remote preconditioning was not evaluated on the patients undergoing off pump coronary artery bypass graft surgery (OPCAB).

The investigators hypothesized that the lower limb remote preconditioning could protect the myocardium during the OPCAB. In this study, the investigators will try to evaluate whether remote preconditioning could induce myocardial protection on the OPCAB patients.

Full description

In recent two clinical trials on the patients undergoing cardiac surgery, remote preconditioning showed very powerful myocardial protection by simple and safe procedures such as the brief inflation of pneumatic tourniquet on the upper or lower limb. However, despite these impressive results, the clinical studies are lacking yet. Moreover, two previous studies were done on the cardiac surgery with cardiopulmonary bypass. Considering different mechanism, level of myocardial injury and the increasing popularity of OPCAB, we need the clinical study on remote preconditioning with the OPCAB patients.

In this study, we will conduct randomized controlled clinical trials in which the remote preconditioning was induced by lower limb ischemia with double-blinded technique. Myocardial injury will be assessed by postoperative serum troponin I levels and they will be compared with those of control group.

Enrollment

68 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult patients undergoing elective off pump coronary artery bypass graft surgery

Exclusion criteria

  • unstable angina
  • preoperative use of inotropics or mechanical assist device,
  • left ventricular ejection fraction less than 30%,
  • major combined operation such as aortic surgery or carotid endarterectomy,
  • severe liver, renal and pulmonary disease,
  • recent myocardial infarction (within 7 days),
  • recent systemic infection or sepsis (within 7 days)
  • peripheral vascular disease affecting lower limbs
  • amputation of the lower limbs

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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