The Diagnosis Value of Serum Marker in Stroke Associated... | NCT02181374

Studies
The Diagnosis Value of Serum Marker in Stroke Associated With Nonvalvular Atrial Fibrillation.

NCT02181374

Sponsor

Xijing Hospital

Status

Unknown status

Last Update Posted

Jan 1, 2016Estimated

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Ischemic Stroke

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

Dec 2015

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

Jan 2012

Primary Completion Date

Sep 2016Estimated

Completion Date

Sep 2016Estimated

First Submitted Date

Jun 3, 2014

First Submission Date that Met QC Criteria

Jul 1, 2014

First Posted Date

Jul 3, 2014Estimated

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

Dec 30, 2015

Last Update Posted Date

Jan 1, 2016Estimated

Name	Class
Tang-Du Hospital	OTHER
First Affiliated Hospital Xi'an Jiaotong University	OTHER
Shaanxi Provincial People's Hospital	OTHER

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 diagnostic value of serum NT - proBNP in stroke associated with nonvalvular atrial fibrilltion.

Detailed Description

All included in the cases in 7 days of blood samples, the detection of serum NT - proBNP.Through the single factor analysis to determine the serum NT - proBNP central source sex stroke prediction values.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The diagnostic value of serum NT - proBNP in stroke associated with nonvalvular atrial fibrilltion	All included in the cases in 7 days of blood samples , the detection of serum NT - proBNP.Through the single factor analysis to determine the prediction values of serum NT - proBNP in stroke associated with nonvalvular atrial fibrilltion.	34 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 ≤ Age ≤ 85;
Meet the clinical diagnostic criteria for acute ischemic stroke;
onset within 7 days;

Exclusion Criteria:

Severe systemic disease (chronic inflammation, infection, blood system diseases, cancer, kidney failure, liver failure,heart failure);
Nearly a month history of myocardial infarction;
pregnant;
Serious neurological disease that the diagnosis is unclear;

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

18 ≤ Age ≤ 85; meet the clinical diagnostic criteria for acute ischemic stroke; onset within 24 hours at the same time more than one hour; it was diagnosed with experiential doctor.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wen Jiang, MD	Contact	02984775361		jiangwen@fmmu.edu.cn

Overall Officials

Name	Affiliation	Role
Wen Jiang, MD	The Department of Neurology, Xijing Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Department of Neurology, Xijing Hospital	Recruiting	Xi'an	Shaanxi	710032	China

Condition Browse Module

MeSH Terms

ID	Term
D000083242	Ischemic Stroke
D001281	Atrial Fibrillation
D000083262	Embolic Stroke

Ancestor Terms

ID	Term
D020521	Stroke
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided