Expression Profiling of microRNA Following Administration... | NCT03213743

Studies
Expression Profiling of microRNA Following Administration of Dexmedetomidine

NCT03213743

Sponsor

First Affiliated Hospital of Kunming Medical University

Status

Completed

Last Update Posted

Jul 11, 2017Actual

Enrollment

3Actual

Phase

Not Applicable

Conditions

Coronary Disease

Interventions

Dexmedetomidine Injection

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 19, 2017Actual

Primary Completion Date

Jun 21, 2017Actual

Completion Date

Jun 21, 2017Actual

First Submitted Date

Jul 7, 2017

First Submission Date that Met QC Criteria

Jul 10, 2017

First Posted Date

Jul 11, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 10, 2017

Last Update Posted Date

Jul 11, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jinqiao Qian, Professor, First Affiliated Hospital of Kunming Medical UniversityPrincipal Investigator

Lead Sponsor

First Affiliated Hospital of Kunming Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the study is to find out the differential expression profiling of microRNA before and after adiministration of dexmedetomidine in patients undergoing procedures, and then investigators will do some in vitro studies to validate the functions of the microRNA.

Detailed Description

Background and objective: The use of dexmedetomidine may have benefits on the clinical outcomes of cardiac surgery. MicroRNAs are non-coding RNA sequences that act as regulators of gene expression. Investigators conduct a study to determine the role of microRNAs in cardioprotection mediated by dexmedetomidine.

Methods: In this study 3 patients were selected. The blood sample were taken before administration of dexmedetomidine.Investigators infused loading dose of dexmedetomidine for 10 minutes and maintaining dese of dexmedetomidine for 20 minutes.Thirty minutes after the administration, another blood samples were taken and stored in the liquid nitrogen and both the samples were marked. Those sample were analyzed for differentially expressed microRNA with Exiqon miRNA Array.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
before dexmedetomidine	Other	We took blood samples before the administration of dexmedetomidine to determine exression level of microRNA in the subjects.	Drug: Dexmedetomidine Injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexmedetomidine Injection	Drug	Investigators gave the patients loading dose of dexmedetomidine for 10 minutes and maintaining dose of dexmedetomidine for 20 minutes. Investigators took blood samples before and after the administration of dexmedetomidine.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
microRNA differential expression	microRNA differential expression exerts cardioprotection effect on patients undergoing procedures.	30 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The patients without arrithmia will undergo procedure.

Exclusion Criteria:

The patients have bradycardia (hear rate is less than 60 beats per minute) or conduction block.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jinqiao Qian, Ph.D	First Affiliated Hospital of Kunming Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jinqiao Qian		Kunming	Yunnan	650032	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003327	Coronary Disease

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020927	Dexmedetomidine

Ancestor Terms

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided