Trial document




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  DRKS00000707

Trial Description

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Title

biomarkers in cardiology - BIC 9: autoantibodies in acute stroke

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Trial Acronym

BIC-9

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URL of the Trial

[---]*

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Brief Summary in Lay Language

We collect blood a blood sample and important patient-related data of patients who present to our Emergency Rooms within 4.5 hours after onset of symptoms which are typical for an acute stroke. We are seeking to evaluate a group of new laboratory parameters which might help us to distinguish a true stroke from a stroke mimic and to maybe diagnose the cause of the stroke.

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Brief Summary in Scientific Language

The objective of this trial is the evaluation of a group of new biomarkers for the early diagnosis of stroke. These biomarkers might be able to distinguish between hemorrhagic and embolic strokes and might identify lacunar strokes and stroke mimics.
The biomarkers are auto-antibodies which have shown positive results in preliminary studies.

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Organizational Data

  •   DRKS00000707
  •   2011/03/22
  •   [---]*
  •   yes
  •   Approved
  •   EA2/155/10, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  •   U1111-1119-7602 
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Health Condition or Problem studied

  •   I63 -  Cerebral infarction
  •   I64 -  Stroke, not specified as haemorrhage or infarction
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Interventions/Observational Groups

  •   Blood draw in the process of emergency care/management. No further study-related measures.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   [---]*
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Primary Outcome

Final diagnosis as reported in the final hospital report written by the Department of Neurology. Documentation in the eCRF.

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Secondary Outcome

Stroke mimics: Diagnosis of patients at point of discharge from the hospital.
Patients were hospitalized with suspected acute stroke, further treatment during hospitalization lead to a different diagnosis.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2011/03/07
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Full age
Patient suspected of acute stroke
admission to ED within 4.5 hours of onset of symptoms

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Exclusion Criteria

life expectancy below 6 months
Minors
status of dependency with PI
Detention by law

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Addresses

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    • Charité Berlin Arbeitsbereich Notfallmedizin CVK und CCM Medizinische Klinik m.S. Kardiologie
    • Mr.  Prof.  Martin  Möckel 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Charité - Universitätsmedizin Berlin Klinik und Poliklinik für Neurologie
    • Mr.  Prof. Dr. med.  Matthias  Endres 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Charité Berlin Medizinische Klinik m.S. Kardiologie
    • Ms.  Dr.  Julia  Searle 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Charité Berlin Medizinische Klinik m.S. Kardiologie
    • Ms.  Dr.  Julia  Searle 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Abbott GmbH&Co.KG Research and Development
    • Max-Planck-Ring 2
    • 65205  Wiesbaden-Delkenheim
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting stopped after recruiting started
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.