The UTRAVERA: Study Protocol for a Multicenter Prospective Observational Investigation on Vertigo and Dizziness Due to Vertebrobasilar Transient Neurological Attacks - Diagnoses, Clinical Features, Treatment Responses, and Prognostic Factors.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Diagnostic accuracy of the baseline clinical diagnosis of vertebrobasilar transient neurological attacks (VB-TNA)
Study Overview
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 VBTNAs, 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, to 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. It aims to address diagnostic uncertainty in patients presenting to the emergency department with acute transient vertigo, dizziness, or unsteadiness lasting less than 24 hours and without immediate evidence of stroke on neuroimaging. The study focuses on the spectrum of vertebrobasilar transient neurological attacks (VB-TNAs), a clinical construct encompassing transient vestibular symptoms with or without associated brainstem manifestations, such as diplopia, dysarthria, ataxia, sensory disturbances, or bilateral visual symptoms.
At initial presentation, these episodes may be clinically indistinguishable from vestibular migraine, atypical peripheral vestibular disorders, or other miscellaneous conditions, resulting in a diagnostic grey zone. Adult patients presenting with transient vertigo or dizziness are prospectively enrolled and undergo standardized neurotologic, 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, recurrence of symptoms, treatment responses, and clinical outcomes. Therapeutic interventions are not mandated by the study protocol and 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 initial diagnostic classification over time, evaluate therapeutic outcomes, and identify prognostic factors associated with adverse events such as stroke, recurrent attacks, or death. Through its longitudinal and multicenter design, the UTRAVERA study seeks to improve understanding, risk stratification, and management of patients with transient vertigo and dizziness of uncertain etiology.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Episodic acute vertigo, dizziness or unsteadiness transiente or in evolution, therefore, lasting <24 h. • Such an episode may be isolated or associated with one or more of the following: (a) focal central neurological symptoms or severe postural instability; (b) new-onset, moderate-to-severe craniocervical pain; or (c) 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 fulfills 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 suggested another etiology of dizziness or vertigo.
- •Patients who do not complete the entire evaluation.
- •Patients who refuse to sign the informed consent form.
Arms & Interventions
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
Outcomes
Primary Outcomes
Diagnostic accuracy of the baseline clinical diagnosis of vertebrobasilar transient neurological attacks (VB-TNA)
Time Frame: Up to 12 months.
Proportion of patients in whom the baseline clinical diagnosis of vertebrobasilar transient neurological attacks is confirmed or revised during follow-up, based on clinical reassessment, neuroimaging, and multidisciplinary evaluation.
Secondary Outcomes
- Incidence of stroke and death during follow-up.(Up to 12 months)
- Recurrence of transient neurological or vestibular symptoms.(Up to 12 months.)
- Diagnostic reclassification during follow-up.(Up to 12 months.)
- Treatment response according to final diagnosis.(Up to 12 months.)