Validation of TriAGE+ for Predicting Stroke Risk in ED Patients Presenting With Dizziness
NCT ID: NCT06641050
Last Updated: 2025-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
841 participants
OBSERVATIONAL
2024-06-01
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Validating a Clinical Decision Support Tool for Stratifying Stroke Risk for Dizziness/Vertigo
NCT06010550
STROKE STAT (Stroke Severity-based Triage to Accelerate Treatment)
NCT04978480
Hospital Implementation of a Stroke Protocol for Emergency Evaluation and Disposition
NCT06094478
External Validation of VAN, VES and LARIO Scales in Suspected Acute Stroke
NCT06024330
Comparative Evaluation of Stroke Triage Algorithms for Emergency Medical Dispatchers
NCT01202318
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Cerebrovascular events (CVEs) involving the brain's posterior circulation-supplied by the vertebrobasilar arterial system and including regions such as the cerebellum, medulla oblongata, pons, and midbrain-are a common but often missed cause of dizziness. Studies have shown that 8.4% of patients presenting with isolated dizziness were later diagnosed with a posterior circulation stroke, and isolated dizziness has been recognized as the most common symptom in transient ischemic attacks (TIAs) and posterior circulation strokes.
In cerebellar stroke patients, 10% present with isolated dizziness. However, the National Institutes of Health Stroke Scale (NIHSS), which is commonly used to assess stroke severity, often underestimates posterior circulation strokes due to its focus on symptoms typically associated with anterior circulation infarcts. Posterior circulation strokes make up 20-25% of ischemic strokes, yet they are underdiagnosed 2 to 4 times more frequently than their anterior counterparts.
This diagnostic challenge underscores the need for an effective risk stratification tool to aid clinicians. Although several risk scores for cerebrovascular events exist, including the widely used ABCD2 score developed by Navi et al., they are often inadequate in assessing stroke risk in patients presenting with dizziness, as they emphasize unilateral weakness and speech impairment, both of which are less relevant to posterior circulation strokes.
In 2017, Kuroda et al. developed the TriAGE+ score to specifically predict stroke risk in patients presenting with dizziness. Their study, conducted in Japan across five emergency departments, included 498 patients. The score, which ranges from 0 to 17, was designed to categorize patients into four risk groups: low (\<5), moderate (5-7), high (8-9), and very high (\>9) risk for stroke. A threshold score of 10, determined through Receiver Operating Characteristic (ROC) analysis, provided a balance between sensitivity (77.5%; 95% CI 72.8-81.8) and specificity (72.1%; 95% CI 64.1-79.2). While this study demonstrated that the TriAGE+ score effectively predicted stroke risk, it was limited by its retrospective design and single-region focus, necessitating external validation.
Subsequently, Ho-Kun Yu et al. conducted an external validation study in Hong Kong in 2023, which, though supportive of the score's efficacy, shared similar limitations, including its retrospective, single-center design. As the TriAGE+ score was developed and validated primarily in Asia, it is critical to assess its generalizability and applicability in other populations. Our study seeks to perform an external validation of the TriAGE+ score in Turkey, with the aim of evaluating its safety, applicability, and reliability in a different population.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients with dizziness
Individuals aged 18 years and over who present to the emergency department with dizziness will be assessed using the TriAGE+ score.
Triage+ Score
The TriAGE+ score is used to evaluate the risk of cerebrovascular disease in patients presenting with dizziness. The score assists in determining the necessity of advanced diagnostic evaluation for stroke, potentially improving diagnostic accuracy and patient outcomes.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Triage+ Score
The TriAGE+ score is used to evaluate the risk of cerebrovascular disease in patients presenting with dizziness. The score assists in determining the necessity of advanced diagnostic evaluation for stroke, potentially improving diagnostic accuracy and patient outcomes.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients who provide informed consent, or legal guardians providing consent for patients unable to do so.
Exclusion Criteria
* Patients under the influence of alcohol or substances.
* Pregnant patients.
* Patients previously included in the study.
* Patients who refuse medical treatment or withdraw consent.
* Patients with incomplete data necessary for the study.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Marmara University Pendik Training and Research Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Emre Kudu
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Marmara University Pendik Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
09.2024.240
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.