Biomarker for Rapid Diagnosis of Hemispheric Stroke

NCT00916864 | Completed

• 1 other identifier: BEFAST!-1
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Stroke

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy (sensitivity and specificity for diagnosing cerebral ischemia and intracerebral hemorrhage)

  9 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients admitted with symptoms suspicious of acute hemispheric stroke to primary, secondary and tertiary care hospitals in Europe.

You may qualify if:

• 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

You may not qualify if:

• stroke/TIA within the last 3 months
• traumatic brain injury within the last 3 months
• history of brain tumor

Sponsors & Collaborators

• Johann Wolfgang Goethe University Hospital: lead

Study Sites (1)

Department of Neurology, Goethe-University

Frankfurt am Main, 60590, Germany

Location

Related Publications (3)

• 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.

  PMID: 19018136 BACKGROUND

• 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. doi: 10.1136/jnnp.2005.074823. Epub 2005 Sep 20.

  PMID: 16174653 BACKGROUND

• 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. doi: 10.1373/49.10.1752.

  PMID: 14500616 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Human plasma

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Helmuth Steinmetz, MD

  Department of Neurology, Goethe-University, Frankfurt, Germany

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 9, 2009
• First Posted: June 10, 2009
• Study Start: June 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 23, 2011

Record last verified: 2011-06

Locations

DE (1)