Acute StrokeBE FAST!NCT00916864
Biomarker for Rapid Diagnosis of Hemispheric Stroke
An observational study of Acute Stroke, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke
- How many people
- 250 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2009to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted with symptoms suspicious of acute hemispheric stroke to primary, secondary and tertiary care hospitals in Europe.
Who may be able to join
- 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
Who cannot join
- stroke/TIA within the last 3 months
- traumatic brain injury within the last 3 months
- history of brain tumor
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Neurology, Goethe-University
Frankfurt am Main, 60590
About this study
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
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy (sensitivity and specificity for diagnosing cerebral ischemia and intracerebral hemorrhage)
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Helmuth Steinmetz, MD, Study chair, Department of Neurology, Goethe-University, Frankfurt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00916864
- Sponsor's protocol ID
- BEFAST!-1
- Acronym
- BE FAST!
- Status last verified
- Jun 2011
- First submitted
- 9 Jun 2009
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1159/000172632. Epub 2008 Nov 15.
PubMed 19018136Foerch 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.
PubMed 16174653Dambinova 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.
PubMed 14500616
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker for Rapid Diagnosis of Hemispheric Stroke
- ClinicalTrials.gov ID
- NCT00916864
- Acronym / sponsor ID
- BE FAST! / BEFAST!-1
- Conditions
- Acute Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 10 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted with symptoms suspicious of acute hemispheric stroke to primary, secondary and tertiary care hospitals in Europe.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- stroke/TIA within the last 3 months
- traumatic brain injury within the last 3 months
- history of brain tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic accuracy (sensitivity and specificity for diagnosing cerebral ischemia and intracerebral hemorrhage)
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
- Background: PubMed 19018136Dvorak 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.
- Background: PubMed 16174653Foerch 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.
- Background: PubMed 14500616Dambinova 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helmuth Steinmetz, MD study chair
Department of Neurology, Goethe-University, Frankfurt, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Stroke, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy (sensitivity and specificity for diagnosing cerebral ischemia and intracerebral hemorrhage) (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00916864, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2011.