Effects of Ischemic Postconditioning on MicroRNAs in Double Valve Replacement

Overview

1. Cardiopulmonary bypass and cardioplegic arrest could regulate expression of microRNAs in patients undergoing double valve replacement (aortic and mitral).

2. The modulation of myocardial microRNAs by cardiopulmonary bypass and cardioplegic arrest may be rescued by ischemic postconditioning.

3. Downstream effectors would also be affected.

Full Title of Study: “Effects of Ischemic Postconditioning on Expression of Apoptosis-related MicroRNAs and Genes in Human Double Valve Replacement”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 2013

Interventions

  • Procedure: ischemic postconditioning
    • 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.
  • Procedure: double valve replacement
    • The double valve replacement is a procedure in which surgery is used to replace diseased aortic and mitral heart valves.
  • Device: heart-lung machine
    • The heart-lung machine is commonly used in open heart surgery including double valve replacement to support the circulation during the operation.
  • Device: Aortic cross-clamp
    • a surgical instrument used in cardiac surgery to clamp the aorta

Arms, Groups and Cohorts

  • Sham Comparator: CON
    • Patients undergoing double valve replacement (aortic and mitral).
  • Experimental: IPO
    • Patients undergoing double valve replacement (aortic and mitral) with ischemic postconditioning.

Clinical Trial Outcome Measures

Primary Measures

  • Change from Baseline in Cardiac MicroRNA Expression
    • Time Frame: before cardiopulmonary bypass and at 5 min after aortic de-clamping
    • 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.

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Central South University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Luo Wanjun, Prof. – Central South University
  • Overall Official(s)
    • Wanjun Luo, MD, Principal Investigator, Xiangya Hospital of Central South University

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