Effects of Ischemic Postconditioning on MicroRNAs in Double Valve Replacement

NCT ID: NCT01804283

Last Updated: 2013-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiopulmonary Bypass Ischemic Postconditioning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CON

Patients undergoing double valve replacement (aortic and mitral).

Group Type SHAM_COMPARATOR

double valve replacement

Intervention Type PROCEDURE

The double valve replacement is a procedure in which surgery is used to replace diseased aortic and mitral heart valves.

heart-lung machine

Intervention Type DEVICE

The heart-lung machine is commonly used in open heart surgery including double valve replacement to support the circulation during the operation.

Aortic cross-clamp

Intervention Type DEVICE

a surgical instrument used in cardiac surgery to clamp the aorta

IPO

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

Group Type EXPERIMENTAL

ischemic postconditioning

Intervention Type PROCEDURE

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.

double valve replacement

Intervention Type PROCEDURE

The double valve replacement is a procedure in which surgery is used to replace diseased aortic and mitral heart valves.

heart-lung machine

Intervention Type DEVICE

The heart-lung machine is commonly used in open heart surgery including double valve replacement to support the circulation during the operation.

Aortic cross-clamp

Intervention Type DEVICE

a surgical instrument used in cardiac surgery to clamp the aorta

Interventions

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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.

Intervention Type PROCEDURE

double valve replacement

The double valve replacement is a procedure in which surgery is used to replace diseased aortic and mitral heart valves.

Intervention Type PROCEDURE

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.

Intervention Type DEVICE

Aortic cross-clamp

a surgical instrument used in cardiac surgery to clamp the aorta

Intervention Type DEVICE

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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central South University

OTHER

Sponsor Role lead

Responsible Party

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Luo Wanjun

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wanjun Luo, MD

Role: PRINCIPAL_INVESTIGATOR

Xiangya Hospital of Central South University

Locations

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Xiangya Hospital

Changsha, Hunan, China

Site Status

Countries

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China

Facility Contacts

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Wanjun Luo, MD

Role: primary

86-731-89753003

References

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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.

Reference Type DERIVED
PMID: 26253453 (View on PubMed)

Other Identifiers

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CmiR-001

Identifier Type: -

Identifier Source: org_study_id

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