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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Lower Limb Remote Preconditioning on Myocardial Injury in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery

Conditions
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Ischemic Heart Disease

Intervention / Treatment
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* Procedure: remote ischemic preconditioning


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: remote ischemic preconditioning|remote ischemic preconditioning (4 x 5 min lower limb ischemia with pneumatic cuff up to 200 mmHg with an intervening 5 min reperfusion; 2 cycles; before and after the coronary anastomosis )|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative serum troponin I levels |  | postoperatibe 1, 6, 12, 24, 48, 72 hr | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OPCAB, RIPC