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BRAIN (Biomarker Rapid Assessment of Ischemic iNjury)

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ClinicalTrials.gov Identifier: NCT00206908
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : July 22, 2015
Sponsor:
Information provided by:
Biosite

Tracking Information
First Submitted Date September 13, 2005
First Posted Date September 21, 2005
Last Update Posted Date July 22, 2015
Study Start Date July 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00206908 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 BRAIN (Biomarker Rapid Assessment of Ischemic iNjury)
Official Title BRAIN (Biomarker Rapid Assessment of Ischemic iNjury)
Brief Summary This project is designed to evaluate the clinical utility of a novel blood test, the Triage Stroke Panel, as an aid in the diagnosis and assessment of stroke. The Triage Stroke Panel test device, used with the Triage MeterPlus, is a rapid, point-of-care immunoassay. The test measures the concentration of various analytes present in EDTA-anticoagulated whole blood or plasma, specifically B-type natriuretic peptide (BNP), fibrin degradation products containing D-Dimer, matrix metalloproteiase-9 (MMP-9), and S-100B. The test utilizes a proprietary algorithm for the automatic calculation of a single Multimarker Index (MMX) result from the individual biomarker values. The MMX result is being evaluated for use as an aid in the assessment and diagnosis of stroke.
Detailed Description To date, there is no commercially available blood test approved in the United States for use as an aid in the assessment and diagnosis of stroke. There have been various reports in the scientific literature describing the ability of various biomarkers to predict or identify stroke, with varied success. A biomarker panel approach, similar to that used for the evaluation of chest pain patients (troponin I, CK-MB, and myoglobin) enhances diagnostic accuracy, particularly when the panel includes protein markers associated with various components of the disease pathophysiology. This study involves a retrospective analysis of data collected from patients that present with an acute focal neurological deficit, suspected cerebral ischemia, or suspected intracranial hemorrhage within 24 hours of symptom onset or last known well time will be enrolled into the study. Blood samples will be collected at enrollment and serially up to 72 hrs. from the time of onset or last known well time. The study population will also include a subset of patients with subarachnoid hemorrhage, who will have additional samples collected daily from day 3 through day 14 (at clinical sites participating in the vasospasm substudy) for the evaluation of cerebral vasospasm. The patient's participation in the study is complete when all samples have been collected or when they are discharged from the hospital, whichever occurs first. All blood sample will be analyzed using the Triage Stroke Panel test. Measurements will be performed at each clinical site and at Biosite (subject to test device availability). In order to minimize bias and eliminate significant risk to the patient, physicians will be blinded to all Triage Stroke Panel results during the course of the study. Completed case report forms (CRFs) and frozen plasma samples will be transferred to Biosite.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Cerebral ischemia or intracranial hemorrhage suspected.
Condition
  • Stroke
  • Stroke Mimic(Conditions Presenting With Stroke-like Conditions)
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 Completed
Enrollment
 (submitted: September¬†13,¬†2005)
900
Original Enrollment Same as current
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

Age 18 and above Cerebral ischemia or intracranial hemorrhage suspected Enrollment within 24 hrs from symptom onset or last well-known time

Exclusion Criteria:

None

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   Germany,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00206908
Other Study ID Numbers 003
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor Biosite
Collaborators Not Provided
Investigators
Principal Investigator: Daniel Laskowitz, MD Duke University Hospital
PRS Account Biosite
Verification Date July 2015