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

This study has been completed.
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00916864
First received: June 9, 2009
Last updated: June 22, 2011
Last verified: June 2011
  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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Diagnostic accuracy (sensitivity and specificity for diagnosing cerebral ischemia and intracerebral hemorrhage) [ Time Frame: 9 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00916864

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

Publications:
Responsible Party: Prof. Dr. Helmuth Steinmetz, Department of Neurology, Goethe-University, Frankfurt am Main, Germany
ClinicalTrials.gov Identifier: NCT00916864     History of Changes
Other Study ID Numbers: BEFAST!-1
Study First Received: June 9, 2009
Last Updated: June 22, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on April 16, 2014