Effects of Ischemic Postconditioning on MicroRNAs in Double Valve Replacement

March 3, 2013 updated by: Luo Wanjun, Central South University

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

  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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410008
        • Xiangya Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
SHAM_COMPARATOR: CON
Patients undergoing double valve replacement (aortic and mitral).
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
EXPERIMENTAL: IPO
Patients undergoing double valve replacement (aortic and mitral) with ischemic postconditioning.
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
before cardiopulmonary bypass and at 5 min after aortic de-clamping

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central South University

Investigators

  • Principal Investigator: Wanjun Luo, MD, Xiangya Hospital of Central South University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ANTICIPATED)

March 1, 2013

Study Registration Dates

First Submitted

February 23, 2013

First Submitted That Met QC Criteria

March 3, 2013

First Posted (ESTIMATE)

March 5, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 5, 2013

Last Update Submitted That Met QC Criteria

March 3, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CmiR-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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