We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00916864
First Posted: June 10, 2009
Last Update Posted: June 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Johann Wolfgang Goethe University Hospital
  Purpose
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
Acute Stroke

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Biomarker for Rapid Diagnosis of Hemispheric Stroke

Further study details as provided by Johann Wolfgang Goethe University Hospital:

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

Biospecimen Retention:   Samples Without DNA
Human plasma

Estimated Enrollment: 250
Study Start Date: June 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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