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Biomarker for Rapid Diagnosis of Hemispheric Stroke (BE FAST!)

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ClinicalTrials.gov Identifier: NCT00916864
Recruitment Status : Completed
First Posted : June 10, 2009
Last Update Posted : June 23, 2011
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospital

Brief Summary:
The aim of the study is to estimate the diagnostic accuracy of a combined biomarker test (including NMDA-Receptor fragments [NR2-peptide] and Glial fibrillary acidic protein) used to differentiate between cerebral ischemia and intracerebral hemorrhage in patients with acute hemispheric stroke.

Condition or disease
Acute Stroke

Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Biomarker for Rapid Diagnosis of Hemispheric Stroke
Study Start Date : June 2009
Primary Completion Date : June 2011
Study Completion Date : June 2011



Primary Outcome Measures :
  1. Diagnostic accuracy (sensitivity and specificity for diagnosing cerebral ischemia and intracerebral hemorrhage) [ Time Frame: 9 months ]

Biospecimen Retention:   Samples Without DNA
Human plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients admitted with symptoms suspicious of acute hemispheric stroke to primary, secondary and tertiary care hospitals in Europe.
Criteria

Inclusion Criteria:

  • hemiparesis
  • at least one sign of cortical involvement (e.g., aphasia, neglect, gaze deviation, reduced level of consciousness)
  • hospital admission within 4.5 hours after symptom onset

Exclusion Criteria:

  • stroke/TIA within the last 3 months
  • traumatic brain injury within the last 3 months
  • history of brain tumor

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00916864


Locations
Germany
Department of Neurology, Goethe-University
Frankfurt am Main, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Investigators
Study Chair: Helmuth Steinmetz, MD Department of Neurology, Goethe-University, Frankfurt, Germany