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
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, see Learn About Clinical Studies.

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 August 27, 2014