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BRAIN (Biomarker Rapid Assessment of Ischemic iNjury)

Sponsor
Biosite (Other)
Overall Status
Completed
CT.gov ID
NCT00206908
Collaborator
(none)
900
Enrollment
22
Locations
40.9
Patients Per Site

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    BRAIN (Biomarker Rapid Assessment of Ischemic iNjury)
    Study Start Date :
    Jul 1, 2002

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Alabama Neurological Institute Birmingham Alabama United States 35209
      2 University of California, Los Angeles Medical Center Los Angeles California United States 90095
      3 Denver Health Denver Colorado United States 80204
      4 University of Colorado Health Science Center Denver Colorado United States 80262
      5 Hartford Hospital Hartford Connecticut United States 06102
      6 OSF Saint Francis Medical Center Peoria Illinois United States 61637
      7 Kentucky Neuroscience Research Louisville Kentucky United States 40202
      8 University of Massachusettes, Worcester Medical Center Worcester Massachusetts United States 01655
      9 Henry Ford Health System Detroit Michigan United States 48202
      10 Ingham Regional Medical Center Lansing Michigan United States 48823
      11 Henepin County Medical Center Minneapolis Minnesota United States 55415
      12 St. Luke's Health System Kansas City Missouri United States 64111
      13 Duke University Hopsital Durham North Carolina United States 27710
      14 University of Cincinnati Cincinnati Ohio United States 45267
      15 Cleveland Clinic Foundation Cleveland Ohio United States 44195
      16 Hospital at the University of Pennsylvania Philadelphia Pennsylvania United States 19104
      17 University of Pittsburgh Pittsburgh Pennsylvania United States 15213
      18 Sentara Norfolk General Hospital Norfolk Virginia United States 23507
      19 Toronto Western Hospital Toronto Ontario Canada M5T 2S8
      20 Neurologische Universitatsklinik/Heidelberg Heidelberg Germany
      21 CHUV-Lausanne Lausanne Switzerland
      22 University of Nottingham Nottingham United Kingdom NG5 1PB

      Sponsors and Collaborators

      • Biosite

      Investigators

      • Principal Investigator: Daniel Laskowitz, MD, Duke University Hospital

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00206908
      Other Study ID Numbers:
      • 003
      First Posted:
      Sep 21, 2005
      Last Update Posted:
      Jul 22, 2015
      Last Verified:
      Jul 1, 2015
      Additional relevant MeSH terms:
      Stroke
      Disease

      Study Results

      No Results Posted as of Jul 22, 2015