Copeptin and the S-100b Protein in Stroke

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.

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Key information

Conditions

Vertigo, Peripheral Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Diabetes Insipidus Ear Diseases Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Labyrinth Diseases Male Urogenital Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Pituitary Diseases Signs and Symptoms Stroke Urogenital Diseases Urologic Diseases Vascular Diseases Vertigo Vertigo, Brain Stem Vertigo; Central Vertigo; Cerebral Vestibular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

copeptin, PS100

Diagnostic 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.

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

Value of Copeptin and the S-100b Protein Assay in Ruling Out the Diagnosis of Stroke-induced Dizziness Pattern in Emergency Departments

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Jun 5, 2019
Registry last updated: Jun 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed