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CompletedNCT03974464Updated Jun 5, 2019

Copeptin and the S-100b Protein in Stroke

An observational study in Vertigo, Peripheral, Vertigo, Brain Stem and Vertigo; Central, sponsored by Poitiers University Hospital. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-05.

Sponsored by Poitiers University Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
151
Ages
18 Years and older
Sex
All
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Study 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 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.

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Conditions studied

  • Vertigo, Peripheral
  • Vertigo, Brain Stem
  • Vertigo; Central
  • Vertigo; Cerebral

Keywords

  • vertigo
  • stroke
  • copeptin
  • S-100b protein
  • biomarkers
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In context

Vertigo

248 studies on the registry are indexed under Vertigo; 39 are open to participants now.

This study's enrollment of 151 is close to the median of 151 across 50 observational studies indexed under Vertigo.

Browse Vertigo studies →

Lead sponsor

Poitiers University Hospital is the lead sponsor of 310 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Patients without brain imaging (diffusion-weighted magnetic resonance imaging (MRI) or contrast CT scan compatible with the diagnosis) were excluded.
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
151 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • Diagnostic testcopeptin, PS100

    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.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 hour

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03974464
Lead sponsor
Poitiers University Hospital
Responsible party
Sponsor
First posted
Jun 5, 2019
Start date
May 1, 2016
Primary completion
Jan 31, 2018
Completion
Jan 31, 2018
Last update
Jun 5, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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