NCT01804283

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2013

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2013

Completed
Last Updated

March 5, 2013

Status Verified

March 1, 2013

Enrollment Period

Same day

First QC Date

February 23, 2013

Last Update Submit

March 3, 2013

Conditions

Cardiopulmonary BypassIschemic Postconditioning

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change from Baseline in Downstream Gene Expression

    before cardiopulmonary bypass and at 5 min after aortic de-clamping

Study Arms (2)

CON

SHAM COMPARATOR

Patients undergoing double valve replacement (aortic and mitral).

Procedure: double valve replacementDevice: heart-lung machineDevice: Aortic cross-clamp

IPO

EXPERIMENTAL

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

Procedure: ischemic postconditioningProcedure: double valve replacementDevice: heart-lung machineDevice: Aortic cross-clamp

Interventions

ischemic postconditioningPROCEDURE

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.

IPO
double valve replacementPROCEDURE

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

CONIPO
heart-lung machineDEVICE

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

CONIPO
Aortic cross-clampDEVICE

a surgical instrument used in cardiac surgery to clamp the aorta

CONIPO

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consecutive eight patients with rheumatic heart valve disease undergoing elective double valve replacement(aortic and mitral)are considered for participation in this study.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiangya Hospital

Changsha, Hunan, 410008, China

Location

Related Publications (1)

  • 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.

    PMID: 26253453DERIVED

MeSH Terms

Interventions

Ischemic PostconditioningHeart-Lung Machine

Intervention Hierarchy (Ancestors)

TherapeuticsArtificial OrgansSurgical EquipmentEquipment and Supplies

Study Officials

  • Wanjun Luo, MD

    Xiangya Hospital of Central South University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

February 23, 2013

First Posted

March 5, 2013

Study Start

March 1, 2013

Primary Completion

March 1, 2013

Last Updated

March 5, 2013

Record last verified: 2013-03

Locations

CN(1)