Prospective Registry of Vertigo Due to Vertebrobasilar Transient Attacks.

Official title

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.

Overview

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.

Primary outcome measures

• Diagnostic accuracy of the baseline clinical diagnosis of vertebrobasilar transient neurological attacks (VB-TNA) [Time frame: Up to 12 months.]

Secondary outcome measures (4)

• Number of participants with ischemic stroke or death during 12-month follow-up. [Time frame: Up to 12 months]
• Number of participants with recurrence of transient neurological or vestibular symptoms during 12-month follow-up. [Time frame: Up to 12 months.]
• Number of participants with change in diagnostic classification between baseline and 12 months. [Time frame: Up to 12 months.]
• 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. [Time frame: Up to 12 months.]

Eligibility criteria

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:

• focal central neurological symptoms or severe postural instability;
• new-onset, moderate-to-severe craniocervical pain; or
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Brazil · 1 center

• Hospital das Clínicas - University of São Paulo — São Paulo

Publications

• Kim JS, Newman-Toker DE, Kerber KA, Jahn K, Bertholon P, Waterston J, Lee H, Bisdorff A, Strupp M. Vascular vertigo and dizziness: Diagnostic criteria. J Vestib Res. 2022;32(3):205-222. doi: 10.3233/VES-210169. PMID 35367974
• Filippopulos FM, Strobl R, Belanovic B, Dunker K, Grill E, Brandt T, Zwergal A, Huppert D. Validation of a comprehensive diagnostic algorithm for patients with acute vertigo and dizziness. Eur J Neurol. 2022 Oct;29(10):3092-3101. doi: 10.1111/ene.15448. Epub 2022 Jun 29. PMID 35708513
• Edlow JA, Carpenter C, Akhter M, Khoujah D, Marcolini E, Meurer WJ, Morrill D, Naples JG, Ohle R, Omron R, Sharif S, Siket M, Upadhye S, E Silva LOJ, Sundberg E, Tartt K, Vanni S, Newman-Toker DE, Bellolio F. Guidelines for reasonable and appropriate care in the emergency department 3 (GRACE-3): Acute dizziness and vertigo in the emergency department. Acad Emerg Med. 2023 May;30(5):442-486. doi: 1 PMID 37166022
• Tuna MA, Rothwell PM; Oxford Vascular Study. Diagnosis of non-consensus transient ischaemic attacks with focal, negative, and non-progressive symptoms: population-based validation by investigation and prognosis. Lancet. 2021 Mar 6;397(10277):902-912. doi: 10.1016/S0140-6736(20)31961-9. PMID 33676629
• Neto ACL, Kim JS, Bernardo WM, Bittar RSM. Vertigo and dizziness due to vertebrobasilar TIA: a prospective study. Front Stroke. 2024 Oct 2;3:1429068. doi: 10.3389/fstro.2024.1429068. eCollection 2024. PMID 41542262
• Cortese E, Rochelle P, Patel F, Koohi N, Kaski D. Integrated diagnostic algorithm for acute vertigo combining TiTrATE, STANDING, and HINTS: a validation study in the emergency department. Sci Rep. 2025 Jul 14;15(1):25403. doi: 10.1038/s41598-025-11007-9. PMID 40659780
• Kleindorfer DO, Towfighi A, Chaturvedi S, Cockroft KM, Gutierrez J, Lombardi-Hill D, Kamel H, Kernan WN, Kittner SJ, Leira EC, Lennon O, Meschia JF, Nguyen TN, Pollak PM, Santangeli P, Sharrief AZ, Smith SC Jr, Turan TN, Williams LS. 2021 Guideline for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack: A Guideline From the American Heart Association/American Stroke Ass PMID 34024117

Identifiers

NCT: NCT07421973 · UTRAVERA-HCFMUSP

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗