Effects of Ischemic Postconditioning on MicroRNAs in Double Valve Replacement

Study Overview
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Brief Summary
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Cardiopulmonary bypass and cardioplegic arrest could regulate expression of microRNAs in patients undergoing double valve replacement (aortic and mitral). The modulation of myocardial microRNAs by cardiopulmonary bypass and cardioplegic arrest may be rescued by ischemic postconditioning. Downstream effectors would also be affected.

Official Title
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Effects of Ischemic Postconditioning on Expression of Apoptosis-related MicroRNAs and Genes in Human Double Valve Replacement

Conditions
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Cardiopulmonary Bypass, Ischemic Postconditioning

Intervention / Treatment
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* Procedure: ischemic postconditioning
* Procedure: double valve replacement
* Device: heart-lung machine
* Device: Aortic cross-clamp


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consecutive eight patients with rheumatic heart valve disease undergoing elective double valve replacement(aortic and mitral)are considered for participation in this study. Exclusion Criteria: insulin-dependent diabetes mellitus pulmonary, renal, or hepatic failure infective valve disease valve disease with coronary artery disease hypertension emergency and reoperations received aspirin,corticosteroids, or statin preoperatively received preoperative inotropic support

Ages Eligible for Study
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Minimum Age: 20 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: CON<br>Patients undergoing double valve replacement (aortic and mitral). | Procedure: double valve replacement<br>* The double valve replacement is a procedure in which surgery is used to replace diseased aortic and mitral heart valves.<br>Device: heart-lung machine<br>* The heart-lung machine is commonly used in open heart surgery including double valve replacement to support the circulation during the operation.<br>Device: Aortic cross-clamp<br>* a surgical instrument used in cardiac surgery to clamp the aorta<br>|
| Experimental: IPO<br>Patients undergoing double valve replacement (aortic and mitral) with ischemic postconditioning. | Procedure: ischemic postconditioning<br>* multiple brief ischemic-reperfusion episodes immediately after sustained ischemic insult Postconditioning was started at 30 s after aortic cross declamping, and the aorta was re-clamped for 30 s rendering global myocardial ischemia. Meanwhile aortic root suction was established during aortic re-clamping, and thereafter, the aortic clamp was released for 30 s for full myocardial reperfusion. The cycle was repeated three times after cardioplegic arrest.<br>Procedure: double valve replacement<br>* The double valve replacement is a procedure in which surgery is used to replace diseased aortic and mitral heart valves.<br>Device: heart-lung machine<br>* The heart-lung machine is commonly used in open heart surgery including double valve replacement to support the circulation during the operation.<br>Device: Aortic cross-clamp<br>* a surgical instrument used in cardiac surgery to clamp the aorta<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Cardiac MicroRNA Expression | Samples were harvested from all the patients, respectively, before cardiopulmonary bypass and at 5 min after aortic de-clamping. Real-time quantitative stem-loop reverse transcription polymerase chain reaction assay was performed to detect the expression of microRNAs. | before cardiopulmonary bypass and at 5 min after aortic de-clamping | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Downstream Gene Expression | Expressions of messenger RNAs and proteins were quantified for genes which are regulated by above-detected microRNAs. | before cardiopulmonary bypass and at 5 min after aortic de-clamping |