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Effects of Ischemic Postconditioning on MicroRNAs in Double Valve Replacement

Primary Purpose

Cardiopulmonary Bypass, Ischemic Postconditioning

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ischemic postconditioning
double valve replacement
heart-lung machine
Aortic cross-clamp
Sponsored by
Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cardiopulmonary Bypass

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Xiangya Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

CON

IPO

Arm Description

Patients undergoing double valve replacement (aortic and mitral).

Patients undergoing double valve replacement (aortic and mitral) with ischemic postconditioning.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change from Baseline in Downstream Gene Expression
Expressions of messenger RNAs and proteins were quantified for genes which are regulated by above-detected microRNAs.

Full Information

First Posted
February 23, 2013
Last Updated
March 3, 2013
Sponsor
Central South University
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1. Study Identification

Unique Protocol Identification Number
NCT01804283
Brief Title
Effects of Ischemic Postconditioning on MicroRNAs in Double Valve Replacement
Official Title
Effects of Ischemic Postconditioning on Expression of Apoptosis-related MicroRNAs and Genes in Human Double Valve Replacement
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central South University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiopulmonary Bypass, Ischemic Postconditioning

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CON
Arm Type
Sham Comparator
Arm Description
Patients undergoing double valve replacement (aortic and mitral).
Arm Title
IPO
Arm Type
Experimental
Arm Description
Patients undergoing double valve replacement (aortic and mitral) with ischemic postconditioning.
Intervention Type
Procedure
Intervention Name(s)
ischemic postconditioning
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
double valve replacement
Intervention Description
The double valve replacement is a procedure in which surgery is used to replace diseased aortic and mitral heart valves.
Intervention Type
Device
Intervention Name(s)
heart-lung machine
Intervention Description
The heart-lung machine is commonly used in open heart surgery including double valve replacement to support the circulation during the operation.
Intervention Type
Device
Intervention Name(s)
Aortic cross-clamp
Intervention Description
a surgical instrument used in cardiac surgery to clamp the aorta
Primary Outcome Measure Information:
Title
Change from Baseline in Cardiac MicroRNA Expression
Description
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.
Time Frame
before cardiopulmonary bypass and at 5 min after aortic de-clamping
Secondary Outcome Measure Information:
Title
Change from Baseline in Downstream Gene Expression
Description
Expressions of messenger RNAs and proteins were quantified for genes which are regulated by above-detected microRNAs.
Time Frame
before cardiopulmonary bypass and at 5 min after aortic de-clamping

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wanjun Luo, MD
Organizational Affiliation
Xiangya Hospital of Central South University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xiangya Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wanjun Luo, MD
Phone
86-731-89753003
Email
luo3478@yahoo.cn
First Name & Middle Initial & Last Name & Degree
Wanjun Luo, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
26253453
Citation
Gao Y, Huang R, Chen R, Li J, Luo W. Ischemic postconditioning altered microRNAs in human valve replacement. J Surg Res. 2016 Jan;200(1):28-35. doi: 10.1016/j.jss.2015.07.010. Epub 2015 Jul 10.
Results Reference
derived

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Effects of Ischemic Postconditioning on MicroRNAs in Double Valve Replacement

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