Hospital das Clínicas - University of São Paulo
São Paulo, 05403900, Brazil
Location contact
ARLINDO C NETO, PhD
CONTACT
Ji-Soo Kim, PhD
CONTACT
NCT Number: NCT07421973
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
São Paulo, 05403900, Brazil
ARLINDO C NETO, PhD
CONTACT
Ji-Soo Kim, PhD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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:
Contact information is provided by the study sponsor or research team.
ARLINDO C NETO, PhD
CONTACT
Ji-Soo Kim, PhD
CONTACT
University of Sao Paulo General Hospital
Other
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.
Acronym: UTRAVERA
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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