Biomarker for Rapid Diagnosis of Hemispheric Stroke

Acute Stroke Clinical Trial

— BE FAST!  

Official title:

Biomarker for Rapid Diagnosis of Hemispheric Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00916864
• Other study ID #: BEFAST!-1
• Status: Completed
• Phase: N/A
• First received: June 9, 2009
• Last updated: June 22, 2011
• Start date: June 2009
• Est. completion date: June 2011

Study information

• Verified date: June 2011
• Source: Johann Wolfgang Goethe University Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Stroke
• Stroke

Locations

Country	Name	City	State
Germany	Department of Neurology, Goethe-University	Frankfurt am Main

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Dambinova SA, Khounteev GA, Izykenova GA, Zavolokov IG, Ilyukhina AY, Skoromets AA. Blood test detecting autoantibodies to N-methyl-D-aspartate neuroreceptors for evaluation of patients with transient ischemic attack and stroke. Clin Chem. 2003 Oct;49(10):1752-62. — View Citation

Dvorak F, Haberer I, Sitzer M, Foerch C. Characterisation of the diagnostic window of serum glial fibrillary acidic protein for the differentiation of intracerebral haemorrhage and ischaemic stroke. Cerebrovasc Dis. 2009;27(1):37-41. doi: 10.1159/000172632. Epub 2008 Nov 15. — View Citation

Foerch C, Curdt I, Yan B, Dvorak F, Hermans M, Berkefeld J, Raabe A, Neumann-Haefelin T, Steinmetz H, Sitzer M. Serum glial fibrillary acidic protein as a biomarker for intracerebral haemorrhage in patients with acute stroke. J Neurol Neurosurg Psychiatry. 2006 Feb;77(2):181-4. Epub 2005 Sep 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy (sensitivity and specificity for diagnosing cerebral ischemia and intracerebral hemorrhage)		9 months	No