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BRAIN (Biomarker Rapid Assessment of Ischemic iNjury)

20. juli 2015 opdateret af: Biosite
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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding

900

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Toronto Western Hospital
  • Det Forenede Kongerige
      • Nottingham, Det Forenede Kongerige, NG5 1PB
        • University of Nottingham
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35209
        • Alabama Neurological Institute
    • California
      • Los Angeles, California, Forenede Stater, 90095
        • University of California, Los Angeles Medical Center
    • Colorado
      • Denver, Colorado, Forenede Stater, 80204
        • Denver Health
      • Denver, Colorado, Forenede Stater, 80262
        • University of Colorado Health Science Center
    • Connecticut
      • Hartford, Connecticut, Forenede Stater, 06102
        • Hartford Hospital
    • Illinois
      • Peoria, Illinois, Forenede Stater, 61637
        • OSF Saint Francis Medical Center
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40202
        • Kentucky Neuroscience Research
    • Massachusetts
      • Worcester, Massachusetts, Forenede Stater, 01655
        • University of Massachusettes, Worcester Medical Center
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48202
        • Henry Ford Health System
      • Lansing, Michigan, Forenede Stater, 48823
        • Ingham Regional Medical Center
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55415
        • Henepin County Medical Center
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64111
        • St. Luke's Health System
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke University Hopsital
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45267
        • University of Cincinnati
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic Foundation
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Hospital at the University of Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • University of Pittsburgh
    • Virginia
      • Norfolk, Virginia, Forenede Stater, 23507
        • Sentara Norfolk General Hospital
  • Schweiz
      • Lausanne, Schweiz
        • CHUV-Lausanne
  • Tyskland
      • Heidelberg, Tyskland
        • Neurologische Universitatsklinik/Heidelberg

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Cerebral ischemia or intracranial hemorrhage suspected.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Tilbagevirkende kraft

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Biosite

Efterforskere

  • Ledende efterforsker: Daniel Laskowitz, MD, Duke University Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2002

Datoer for studieregistrering

Først indsendt

13. september 2005

Først indsendt, der opfyldte QC-kriterier

13. september 2005

Først opslået (Skøn)

21. september 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

22. juli 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. juli 2015

Sidst verificeret

1. juli 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 003 (033)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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