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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Central South University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2013

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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