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

History of Changes

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 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:

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. Epub 2008 Nov 15.

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.

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.

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 May 19, 2013

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