Vertigo, PeripheralNCT03974464
Copeptin and the S-100b Protein in Stroke
An observational study of Vertigo, Peripheral and Vertigo, Brain Stem, run by Poitiers University Hospital.
Trial summary
This study evaluated the value of using copetin and protein S 100 b to eliminate the diagnosis of stroke in patients presenting with vertigo in emergency departments. All patients benefited from the S 100b protein assay, copeptin and brain MRI. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vertigo, Peripheral, Vertigo, Brain Stem, Vertigo; Central
- What is being tested?
- copeptin, PS100
- How many people
- 151 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2016to 31 Jan 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: One hundred and fifty-one patients were included, of whom 16 were secondarily excluded (lost to follow-up n=1, missing biomarkers n=9, missing MRI n=6)(Figure 1). A majority of the remaining 135 patients were women (n=79, 59%) with an average age of 62 years . Specialized advice on the origin of dizziness was sought from ENT and/or neurologist in 102 (76%) of cases. Patients received brain diffusion-weighted MRI alone in 74 cases, contrast brain CT alone in 11 cases and a combination of MRI and CT in 50 cases. In 122 patients (90%), vertigo was not related to stroke.
Who may be able to join
- We included patients 18 years of age or older, visiting the ED for a new episode of dizziness evolving less than 72 hours and having given written consent to participate in the study
Who cannot join
- Patients without brain imaging (diffusion-weighted magnetic resonance imaging (MRI) or contrast CT scan compatible with the diagnosis) were excluded.
About this study
Official title: Value of Copeptin and the S-100b Protein Assay in Ruling Out the Diagnosis of Stroke-induced Dizziness Pattern in Emergency Departments
This study evaluated the value of using copetin and protein S 100 b to eliminate the diagnosis of stroke in patients presenting with vertigo in emergency departments. All patients benefited from the S 100b protein assay, copeptin and brain MRI.
Read the detailed description
Vertigo is a frequent reason for visiting emergency departments. Differentiating stroke from other causes is challenging for physicians. The role of biomarkers has been poorly assessed. Evaluators evaluated whether copeptin and S100b protein assessment, alone or in combination, could rule out stroke in patients visiting emergency departments for vertigo.
Evaluators included patients visiting the adult emergency departments of a French university hospital for a new episode of vertigo evolving for less than 72 hours. All patients underwent standardized physical examination (HINT [Head Impulse test, Nystagmus, test of skew deviation] maneuvers), copeptin and S-100b protein measurement and injected brain imaging. Stroke diagnosis involved diffusion-weighted magnetic resonance imaging or, if not available, neurological examination and contrast brain CT scan compatible with the diagnosis.
- Being tested
- copeptin, PS100
- Keywords
- vertigo, stroke, copeptin, S-100b protein, biomarkers
- Medical subject headings
- Vertigo, Stroke, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
copeptin, PS100Diagnostic test
Age, sex and time between dizziness onset and ED visit were collected using Resurgences® software. PS100 concentrations were measured on serum samples by electro-chemiluminescence assay. Copeptin concentrations were measured on serum samples by the Kryptor method. The positivity threshold for copeptin was set at strictly above 10 pmol/L and that of PS100 was set at strictly above 0.105 μmol/L.
And after, we compared results with results of brain imaging: Magnetic Resonance Imaging alone, CT scan alone or both. Depending on clinical presentation, the imaging tests were performed during ED stay, during hospitalization or externally. Presence or absence of stroke was established on diffusion-weighted brain MRI . In case of normal contrast CT alone, a specialized opinion should exclude the need for diffusion-weighted MRI according to clinical presentation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Show that the negativity of S-100b protein and copeptin eliminates stroke in the face of vertigo
negative predictive value of the S-100b protein and copeptin combination
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start1 May 2016
- Primary completion31 Jan 2018
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertigo, PeripheralStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03974464
- Sponsor's protocol ID
- vertigo
- Status last verified
- Jun 2019
- First submitted
- 7 May 2019
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Copeptin and the S-100b Protein Assay in Ruling Out the Diagnosis of Stroke-induced Dizziness Pattern in Emergency Departments
- ClinicalTrials.gov ID
- NCT03974464
- Acronym / sponsor ID
- vertigo
- Keywords
- vertigo, stroke, copeptin, S-100b protein, biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 5 Jun 2019 (actual)
- 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.
This study evaluated the value of using copetin and protein S 100 b to eliminate the diagnosis of stroke in patients presenting with vertigo in emergency departments. All patients benefited from the S 100b protein assay, copeptin and brain MRI.
Detailed description
Vertigo is a frequent reason for visiting emergency departments. Differentiating stroke from other causes is challenging for physicians. The role of biomarkers has been poorly assessed. Evaluators evaluated whether copeptin and S100b protein assessment, alone or in combination, could rule out stroke in patients visiting emergency departments for vertigo.
Evaluators included patients visiting the adult emergency departments of a French university hospital for a new episode of vertigo evolving for less than 72 hours. All patients underwent standardized physical examination (HINT [Head Impulse test, Nystagmus, test of skew deviation] maneuvers), copeptin and S-100b protein measurement and injected brain imaging. Stroke diagnosis involved diffusion-weighted magnetic resonance imaging or, if not available, neurological examination and contrast brain CT scan compatible with the diagnosis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- One hundred and fifty-one patients were included, of whom 16 were secondarily excluded (lost to follow-up n=1, missing biomarkers n=9, missing MRI n=6)(Figure 1). A majority of the remaining 135 patients were women (n=79, 59%) with an average age of 62 years . Specialized advice on the origin of dizziness was sought from ENT and/or neurologist in 102 (76%) of cases. Patients received brain diffusion-weighted MRI alone in 74 cases, contrast brain CT alone in 11 cases and a combination of MRI and CT in 50 cases. In 122 patients (90%), vertigo was not related to stroke.
Key inclusion criteria (1 listed)
- We included patients 18 years of age or older, visiting the ED for a new episode of dizziness evolving less than 72 hours and having given written consent to participate in the study
Key exclusion criteria (1 listed)
- Patients without brain imaging (diffusion-weighted magnetic resonance imaging (MRI) or contrast CT scan compatible with the diagnosis) were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| copeptin, PS100Age, sex and time between dizziness onset and ED visit were collected using Resurgences® software. PS100 concentrations were measured on serum samples by electro-chemiluminescence assay. Copeptin concentrations were measured on serum samples by the Kryptor method. The positivity threshold for copeptin was set at strictly above 10 pmol/L and that of PS100 was set at strictly above 0.105 μmol/L. And after, we compared results with results of brain imaging: Magnetic Resonance Imaging alone, CT scan alone or both. Depending on clinical presentation, the imaging tests were performed during ED stay, during hospitalization or externally. Presence or absence of stroke was established on diffusion-weighted brain MRI . In case of normal contrast CT alone, a specialized opinion should exclude the need for diffusion-weighted MRI according to clinical presentation. | Diagnostic test | – |
Primary outcome
Show that the negativity of S-100b protein and copeptin eliminates stroke in the face of vertigo
Time frame: 1 hour
negative predictive value of the S-100b protein and copeptin combination
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 5 Jun 2019.
- Individual participant dataSharing planned: No
Related trials for Vertigo, Peripheral
Not yet recruiting
Ai Chi-Based Rehabilitation for Peripheral Unilateral Vestibular Dysfunction
Unilateral Peripheral Vestibular Hypofunction, Vestibular Disorders
Not yet recruiting
Clinical Trial of Vit D and Calcium for Recurrent BPPV
BPPV, Benign Paroxysmal Positional Vertigo
Recruiting
The SaVe Project-Sarcopenia and Vertigo in Aging Patients With Colorectal Cancer
Colorectal Cancer, Oncologic Complications
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Vertigo, Peripheral and Vertigo, Brain Stem, run by Poitiers University Hospital.
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 1 inclusion and 1 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 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Show that the negativity of S-100b protein and copeptin eliminates stroke in the face of vertigo (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2019; AzTrials last refreshed its copy on 31 Oct 2026.