Biomarker for Rapid Diagnosis of Hemispheric Stroke

NCT ID: NCT00916864

Last Updated: 2011-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Stroke

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Department of Neurology, Goethe-University, Frankfurt am Main, Germany

Principal Investigators

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Helmuth Steinmetz, MD

Role: STUDY_CHAIR

Department of Neurology, Goethe-University, Frankfurt, Germany

Locations

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Department of Neurology, Goethe-University

Frankfurt am Main, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 19018136 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16174653 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14500616 (View on PubMed)

Other Identifiers

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BEFAST!-1

Identifier Type: -

Identifier Source: org_study_id

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