Potential Diagnostic and Prognostic Value of microRNAs fo... | NCT02835573

Studies
Potential Diagnostic and Prognostic Value of microRNAs for the Patients of Sepsis-induced Myocardial Injury

NCT02835573

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Status

Unknown status

Last Update Posted

Jun 18, 2018Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Sepsis-induced Myocardial Injury

Interventions

Not provided

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

Jun 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2016

Primary Completion Date

Nov 2018Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Jul 11, 2016

First Submission Date that Met QC Criteria

Jul 13, 2016

First Posted Date

Jul 18, 2016Estimated

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

Jun 15, 2018

Last Update Posted Date

Jun 18, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Bin He, M.D./Ph.D., Xinhua Hospital, Shanghai Jiao Tong University School of MedicinePrincipal Investigator

Lead Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 this study is to evaluate the potential diagnostic and prognosis value of circulating microRNAs compared with cTnI for the patients of sepsis-induced myocardial injury at the emergency department (ED) and intensive care unit (ICU).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sepsis-induced myocardial injury group		Patients admitted to the hospital with the diagnosis of Sepsis-induced myocardial injury
Blank control group		Patients admitted to the hospital without the diagnosis of Sepsis-induced myocardial injury

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnostic value of microRNAs evaluate by qPCR in patients of sepsis-induced myocardial injury		Day 7

Secondary Outcomes

Measure	Description	Time Frame
Prognostic value of microRNAs in patients of sepsis-induced myocardial injury		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of sepsis:SOFA score increase >=2 at baseline level induced by infection.
Suspected myocardial injury,including 1 as follows at least:Low blood pressure or using vasoactive drugs; ECG changes(ST segment changes or pathological Q wave); Troponin elevation(> 0.5 μg/L); BNP elevation(> 4670pg/ml); Echocardiography: cardiac function decline(EF<50%).

Exclusion Criteria:

Skeletal muscle damage (induced by orthopedics, vascular surgery or trauma surgical disease, surgery);
Pregnant and lactating women;
Patients with mental disorders;
Patients are using other experimental drugs;
Refusal to provide informed consent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Patients of sepsis-induced myocardial injury

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ethics Committee of Xinhua Hospital	Recruiting	Shanghai	Shanghai Municipality	200092	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided