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

• ClinicalTrials.gov Identifier: NCT02181374
• Recruitment Status: Unknown
• First Posted: July 3, 2014
• Last Update Posted: January 1, 2016
• Sponsor: Xijing Hospital
• 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

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

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