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The Diagnosis Value of Serum Marker in Stroke Associated With Nonvalvular Atrial Fibrillation. (CE)

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ClinicalTrials.gov Identifier: NCT02181374
Recruitment Status : Unknown
Verified December 2015 by Xijing Hospital.
Recruitment status was:  Recruiting
First Posted : July 3, 2014
Last Update Posted : January 1, 2016
Sponsor:
Collaborators:
Tang-Du Hospital
First Affiliated Hospital Xi'an Jiaotong University
Shaanxi Provincial People's Hospital
Information provided by (Responsible Party):
Xijing Hospital

Tracking Information
First Submitted Date June 3, 2014
First Posted Date July 3, 2014
Last Update Posted Date January 1, 2016
Study Start Date January 2012
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 30, 2015)
The diagnostic value of serum NT - proBNP in stroke associated with nonvalvular atrial fibrilltion [ Time Frame: 34 months ]
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.
Original Primary Outcome Measures
 (submitted: July 1, 2014)
The diagnostic value of serum NT - proBNP and D-dimer for cardioembolic stroke [ Time Frame: 34 months ]
All included in the cases in 24 hours, 48 hours, 72 hours of blood samples (more than 24 hours, the collection for 48 hours, 72 hours; more than 48 hours, collecting 72 hours), the detection of serum NT - proBNP and DD.Through the single factor analysis to determine the prediction values of serum NT - proBNP and DD in cardioembolic stroke.
Change History Complete list of historical versions of study NCT02181374 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Diagnosis Value of Serum Marker in Stroke Associated With Nonvalvular Atrial Fibrillation.
Official Title The Diagnosis Value of Serum Marker in Stroke Associated With Nonvalvular Atrial Fibrillation
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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Retention:   Samples Without DNA
Description:
NT-proBNP
Sampling Method Probability Sample
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.
Condition Ischemic Stroke
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: July 1, 2014)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2016
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
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;
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT02181374
Other Study ID Numbers Xijing-25
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Xijing Hospital
Study Sponsor Xijing Hospital
Collaborators
  • Tang-Du Hospital
  • First Affiliated Hospital Xi'an Jiaotong University
  • Shaanxi Provincial People's Hospital
Investigators
Study Director: Wen Jiang, MD The Department of Neurology, Xijing Hospital
PRS Account Xijing Hospital
Verification Date December 2015