Prospective Registry of Vertigo Due to Vertebrobasilar Transient Attacks.
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Sao Paulo General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Episodic acute vertigo, dizziness or unsteadiness transient or in evolution, therefore, lasting <24 h
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.
Disqualifiers
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;
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
400 Participants
are grouped into 4 trial groupsGroup A: VB-TIA
Group B: Migraine-like Disorder
Group C: Miscellaneous
Group D: Unclassified
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
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 months2
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.3
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.4
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.Sponsors and contacts
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University of Sao Paulo General Hospital
Lead sponsor
Seoul National University Bundang Hospital
Collaborator
University of Zurich
Collaborator
University College, London
Collaborator
LMU Klinikum
Collaborator
Source ClinicalTrials.gov
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