Dizziness, TIA (Transient Ischemic Attack), Transient Neurologic Symptoms, Vertigo
Conditions
Keywords
vertigo and dizziness, Vertebrobasilar Transient Neurological Attack, TIA, Vestibular Symptom, Diagnostic Accuracy, Prognostic Factors, Emergency Department
Brief summary
Vertigo and dizziness are common neurological complaints in the emergency department and may represent a wide spectrum of etiologies, including vertebrobasilar transient neurological attacks (VB-TNAs). Distinguishing VB-TNAs, particularly vertebrobasilar transient ischemic attacks (VB-TIAs), from migraine-like and other non-vascular conditions is often challenging at first presentation due to the absence of specific biomarkers and overlapping clinical features. The UTRAVERA study is a multicenter, prospective, observational investigation designed to characterize the clinical features of patients presenting with acute transient vertigo or dizziness suspected to be VB-TNAs. The study will also evaluate diagnostic evolution over time, treatment responses, and prognostic factors associated with clinical outcomes.
Detailed description
The UTRAVERA (Unclassified Transient Vertiginous Attacks) study is a multicenter, prospective, observational cohort study designed in accordance with the SPIRIT 2025 Statement. The study aims to address diagnostic uncertainty in patients presenting to the emergency department with acute transient vertigo, dizziness, or unsteadiness lasting less than 24 hours, with no immediate evidence of stroke on neuroimaging. The study focuses on the spectrum of vertebrobasilar transient neurological attacks (VB-TNAs), a clinical construct that encompasses transient vestibular symptoms with or without associated brainstem manifestations, such as diplopia, dysarthria, ataxia, sensory disturbances, or bilateral visual symptoms. Initially, these episodes may be indistinguishable from vestibular migraine, atypical peripheral vestibular disorders, or other miscellaneous conditions, resulting in a diagnostic gray zone. Adult patients presenting with transient vertigo or dizziness are prospectively enrolled and undergo standardized otologic, neurological, cardiovascular, and imaging evaluations, including diffusion-weighted MRI and vascular imaging of the vertebrobasilar circulation. Based on baseline findings and longitudinal follow-up, patients are classified into diagnostic categories, including VB-TIA, migraine-like disorder, miscellaneous causes, or unclassified attacks. Follow-up assessments are performed at three and six months to evaluate diagnostic reclassification, symptom recurrence, treatment responses, and clinical outcomes. The study protocol does not mandate therapeutic interventions, which reflect standard clinical care, particularly antithrombotic strategies in patients suspected of VB-TIA. The primary objectives of the study are to describe the clinical characteristics of VB-TNAs, assess the accuracy of the initial diagnostic classification over time, evaluate therapeutic outcomes, and identify prognostic factors associated with adverse events.
Interventions
None listed
Sponsors
University of Sao Paulo General Hospital
Seoul National University Bundang Hospital
University of Zurich
University College, London
LMU Klinikum
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Episodic acute vertigo, dizziness or unsteadiness transient or in evolution, therefore, lasting \<24 h * Such an episode may be isolated or associated with one or more of the following: 1. focal central neurological symptoms or severe postural instability; 2. new-onset, moderate-to-severe craniocervical pain; or 3. symptoms that are not better accounted for by another disease or disorder.
Exclusion criteria
* Patients who present with findings of acute hemorrhage or ischemia on the cranial magnetic resonance imaging (MRI), including diffusion-weighted MRI (DWI-MRI) at recruitment; * Patients who also fulfill the diagnostic criteria for other neurotological diseases that may present acute or recurrent transient dizziness/Vertigo (Unilateral Vestibulopathy; benign paroxysmal positional vertigo; Meniére's disease; Vestibular Migraine; Vestibular Paroxysmia; Persistente Postural-Perceptual Dizziness; and Postural Hypotension; * Patients whose symptoms last more than 24 hours or who have evidence of sequelae during follow-up; * Patients with contraindications to any of the therapeutic options proposed by this study method; * Patients who have other symptoms during the follow-up that suggest another etiology of dizziness or vertigo; * Patients who do not complete the entire evaluation; * Patients who refuse to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy of the baseline clinical diagnosis of vertebrobasilar transient neurological attacks (VB-TNA) | Up to 12 months. | The proportion of patients for whom the initial clinical diagnosis of vertebrobasilar transient neurological attacks is confirmed or revised during follow-up based on clinical reassessment, neuroimaging, and a multidisciplinary evaluation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with ischemic stroke or death during 12-month follow-up. | Up to 12 months | The number of enrolled participants who experienced an ischemic stroke (clinically diagnosed and/or confirmed by neuroimaging) or died from any cause during the 12 months following the index event. |
| Number of participants with recurrence of transient neurological or vestibular symptoms during 12-month follow-up. | Up to 12 months. | The number of participants who reported new episodes of transient focal neurological or vestibular symptoms during the 12-month follow-up period after the index event. |
| Number of participants with change in diagnostic classification between baseline and 12 months. | Up to 12 months. | The number of participants whose final diagnosis at 12 months differs from their initial classification (e.g., vertebrobasilar transient neurological attack, vestibular migraine, other causes, or unclassified). |
| Number of participants with death, ischemic stroke, or recurrent vertebrobasilar transient neurological attack during 12-month follow-up among participants with final diagnosis of VB-TIA receiving prescribed treatment. | Up to 12 months. | The number of participants in the VB-TIA subgroup who experienced any of the following during follow-up after initiation of the prescribed treatment following the index event: 1. death from any cause, 2. stroke (clinically diagnosed and/or confirmed by neuroimaging), or 3. recurrent TNA event (a new episode meeting the study's predefined VB-TNA criteria). |
Countries
Brazil
Contacts
CONTACTARLINDO C NETO, PhD
CONTACTJi-Soo Kim, PhD
STUDY_CHAIRJi-Soo Kim, PhD
Seoul National University Bundang Hospital
Outcome results
None listed