The UTRAVERA: a Multicenter Prospective Observational Investigation on Vertigo and Dizziness Due to Vertebrobasilar Transient Neurological Attacks - Diagnoses, Clinical Features, Treatment Responses, and Prognostic Factors.
| Registry | NCT07421973, acronym UTRAVERA |
|---|---|
| Status | Not yet recruiting |
| Study type | Observational |
| Enrollment | 400 (Estimated) |
| Sponsor | University of Sao Paulo General Hospital (Other); collaborators: Seoul National University Bundang Hospital, University of Zurich, University College, London, LMU Klinikum |
| Conditions | Vertigo, Dizziness, TIA (Transient Ischemic Attack), Transient Neurologic Symptoms |
| Dates | start 2026-05-01 (estimated), primary completion 2028-05-30 (estimated), completion 2028-10-01 (estimated), first posted 2026-02-19, last updated 2026-02-27 |
| Locations | 1 site in Brazil |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| VB-TIA | Patients who experience TNAs due to a probable vascular cause and who meet one of the following criteria: (a) increased risk for vascular events, for example, ABCD2 score of 4 or greater or atrial fibrillation; (b) significant (>50%) narrowing of an artery in the vertebrobasilar (VB) system; (c) significant arterial hypoplasia or dolichoectasia; (d) an arterial malformation that favors ischemic events; and (e) isolated spontaneous episodic vertigo/dizziness in older adults with no other possible causes. | ||
| Migraine-like Disorder | Aplied in patients with no cardiovascular risk profile, and TNAs associated to one of the following: (a) evidence of migraine in previous history, or during the follow-up; (b) current headache that fulfils migraine criteria; (c) current or previous symptoms of motion sickness. | ||
| Miscellaneous | Comprise different diagnoses such as hypertensive crisis, functional attacks, atipical BPPV, and rare central disorders such as multiple sclerosis, tumors, or encephalitis. | ||
| Unclassified | Patients who do not fullfil any of the previous, and have symptom constellations that are not characteristic of any distinct etiology |
Sex: All, ages: 18 Years to any
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Hospital das Clínicas - University of São Paulo | São Paulo, São Paulo | Brazil |