An observational study in Vertigo, Dizziness and TIA (Transient Ischemic Attack), sponsored by University of Sao Paulo General Hospital. Not yet recruiting at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by University of Sao Paulo General Hospital · Observational
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.
187 studies on the registry are indexed under Vertigo; 27 are open to participants now.
This study's planned enrollment of 400 is above the median of 198 across 42 observational studies indexed under Vertigo.
Browse Vertigo studies →University of Sao Paulo General Hospital is the lead sponsor of 611 studies on the registry; 98 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Adults presenting with acute or transient episodes of vertigo, dizziness, or unsteadiness that suggest vertebrobasilar transient neurological attacks will be evaluated in emergency departments or outpatient neurotology/neurology settings. Participants will be prospectively enrolled based on predefined clinical criteria and followed longitudinally to assess diagnostic confirmation, clinical characteristics, treatment responses, and prognostic outcomes.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Such an episode may be isolated or associated with one or more of the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Comprise different diagnoses such as hypertensive crisis, functional attacks, atipical BPPV, and rare central disorders such as multiple sclerosis, tumors, or encephalitis.
Patients who do not fullfil any of the previous, and have symptom constellations that are not characteristic of any distinct etiology
Diagnostic accuracy of the baseline clinical diagnosis of vertebrobasilar transient neurological attacks (VB-TNA)
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.
Number of participants with ischemic stroke or death during 12-month follow-up.
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
Number of participants with recurrence of transient neurological or vestibular symptoms during 12-month follow-up.
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.
Number of participants with change in diagnostic classification between baseline and 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.
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.
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).
Time frame: Up to 12 months.
Plan to share: Yes — De-identified individual participant data underlying the results reported in publications, including demographic, clinical, imaging-derived categorical variables, and outcome measures.
Supporting information: Statistical analysis plan
Time frame: Individual participant data (IPD) and supporting documents will be available beginning 6 months after publication of the primary study results and will remain available for a period of 5 years thereafter.
Access criteria: Access to de-identified individual participant data and supporting documents will be granted to qualified researchers who submit a methodologically sound proposal addressing research questions consistent with the objectives of the UTRAVERA study. Requests will be reviewed by the study steering committee. Data access will be provided following approval and execution of a data use agreement.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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