Stroke, IschemicNCT06641050
Validation of TriAGE+ for Predicting Stroke Risk in ED Patients Presenting With Dizziness
An observational study of Stroke, Ischemic, run by Marmara University Pendik Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Ischemic cerebrovascular diseases originating from the brain's posterior circulation account for 20-25% of cases. Among patients diagnosed with cerebellar infarction, 10% present with isolated dizziness as their sole symptom. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- TRIAGE+ score assessment
- How many people
- 818 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 30 Sep 2025
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: The study will include adult (>18 years old) patients presenting to the emergency department with dizziness. These patients must provide informed consent, or consent must be obtained from their legal guardians if the patients are unable to do so. This population will serve as the basis for externally validating the TriAGE+ score, developed in Japan, in a Turkish emergency department setting.
Who may be able to join
- Patients with dizziness who presented to the emergency department
- Patients who provide informed consent, or legal guardians providing consent for patients unable to do so.
Who cannot join
- Patients whose primary symptom is syncope or presyncope, or who present with dizziness due to hemodynamic compromise from gastrointestinal bleeding or other major events.
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Pendik Training and Research Hospital
Istanbul
About this study
Official title: External Validation of the TriAGE+ Score for Predicting Cerebrovascular Disease Risk in Patients Presenting With Dizziness in the Emergency Department
Ischemic cerebrovascular diseases originating from the brain's posterior circulation account for 20-25% of cases. Among patients diagnosed with cerebellar infarction, 10% present with isolated dizziness as their sole symptom. Notably, posterior circulation strokes and cerebellar infarcts are misdiagnosed 2 to 4 times more frequently than anterior circulation strokes. In 2017, Kuroda et al. developed the TriAGE+ score to assess stroke risk in patients presenting with dizziness. This study aims to externally validate the TriAGE+ score, focusing on its safety, applicability, and reliability in predicting cerebrovascular disease in the emergency department.
Read the detailed description
Dizziness is a frequent complaint in emergency departments (ED), accounting for approximately 4% of visits. Epidemiological studies suggest that 3-20% of these patients experience dizziness due to cerebrovascular causes. In Turkey, data collected from 2013 to 2017 indicate that 2.4% of ED visits involved dizziness, with 36.8% of those patients being hospitalized due to central neurological events.
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
- Stroke, Ischemic
- Being tested
- TRIAGE+ score assessment
- Keywords
- Triage+, Cerebrovascular Accident, Dizzyness, Neurologic Deficits
- Medical subject headings
- Ischemic Stroke, Stroke, Dizziness, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRIAGE+ score assessmentOther
The TRIAGE+ score will be recorded or calculated in adults presenting to the emergency department with dizziness. The score will be evaluated for its association with cerebrovascular events occurring within 30 days. No study-directed treatment, imaging strategy, medication, or management decision will be assigned by the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Patients with dizziness | Adults aged 18 years or older presenting to the emergency department with dizziness will be enrolled and followed for 30 days to assess the occurrence of cerebrovascular events, including stroke. No treatment or diagnostic intervention will be assigned by the study protocol. Clinical evaluation and management will be performed according to routine emergency department practice. Receives: Other: TRIAGE+ score assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke
Stroke will be defined as a new diagnosis of acute ischemic stroke or intracranial hemorrhage occurring within 30 days after the index emergency department visit for dizziness. The diagnosis will be based on clinical evaluation supported by neuroimaging findings, including cranial computed tomography and/or magnetic resonance imaging, and/or documentation by a neurologist or treating physician in the medical record.
Measured: 30 days (patient will be followed up 30 days based on their initial visit with dizziness. During the 30-day period, any subsequent visits to relevant specialities or the emergency department will be reviewed to assess for a stroke diagnosis.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Mar 2024
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 818 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Marmara University Pendik Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emre Kudu, Marmara University Pendik Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641050
- Sponsor's protocol ID
- 09.2024.240
- Status last verified
- May 2026
- First submitted
- 11 Oct 2024
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Validation of the TriAGE+ Score for Predicting Cerebrovascular Disease Risk in Patients Presenting With Dizziness in the Emergency Department
- ClinicalTrials.gov ID
- NCT06641050
- Acronym / sponsor ID
- 09.2024.240
- Conditions
- Stroke, Ischemic
- Keywords
- Triage+, Cerebrovascular Accident, Dizzyness, Neurologic Deficits
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 818 participants (actual)
- Lead sponsor
- Marmara University Pendik Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ischemic cerebrovascular diseases originating from the brain's posterior circulation account for 20-25% of cases. Among patients diagnosed with cerebellar infarction, 10% present with isolated dizziness as their sole symptom. Notably, posterior circulation strokes and cerebellar infarcts are misdiagnosed 2 to 4 times more frequently than anterior circulation strokes. In 2017, Kuroda et al. developed the TriAGE+ score to assess stroke risk in patients presenting with dizziness. This study aims to externally validate the TriAGE+ score, focusing on its safety, applicability, and reliability in predicting cerebrovascular disease in the emergency department.
Detailed description
Dizziness is a frequent complaint in emergency departments (ED), accounting for approximately 4% of visits. Epidemiological studies suggest that 3-20% of these patients experience dizziness due to cerebrovascular causes. In Turkey, data collected from 2013 to 2017 indicate that 2.4% of ED visits involved dizziness, with 36.8% of those patients being hospitalized due to central neurological events.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with dizziness | – | Other: TRIAGE+ score assessmentAdults aged 18 years or older presenting to the emergency department with dizziness will be enrolled and followed for 30 days to assess the occurrence of cerebrovascular events, including stroke. No treatment or diagnostic intervention will be assigned by the study protocol. Clinical evaluation and management will be performed according to routine emergency department practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study will include adult (>18 years old) patients presenting to the emergency department with dizziness. These patients must provide informed consent, or consent must be obtained from their legal guardians if the patients are unable to do so. This population will serve as the basis for externally validating the TriAGE+ score, developed in Japan, in a Turkish emergency department setting.
Key inclusion criteria (2 listed)
- Patients with dizziness who presented to the emergency department
- Patients who provide informed consent, or legal guardians providing consent for patients unable to do so.
Key exclusion criteria (6 listed)
- Patients whose primary symptom is syncope or presyncope, or who present with dizziness due to hemodynamic compromise from gastrointestinal bleeding or other major events.
- Patients under the influence of alcohol or substances.
- Pregnant patients.
- Patients previously included in the study.
- Patients who refuse medical treatment or withdraw consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRIAGE+ score assessmentThe TRIAGE+ score will be recorded or calculated in adults presenting to the emergency department with dizziness. The score will be evaluated for its association with cerebrovascular events occurring within 30 days. No study-directed treatment, imaging strategy, medication, or management decision will be assigned by the study protocol. | Other | Patients with dizziness |
Primary outcome
Stroke
Time frame: 30 days (patient will be followed up 30 days based on their initial visit with dizziness. During the 30-day period, any subsequent visits to relevant specialities or the emergency department will be reviewed to assess for a stroke diagnosis.)
Stroke will be defined as a new diagnosis of acute ischemic stroke or intracranial hemorrhage occurring within 30 days after the index emergency department visit for dizziness. The diagnosis will be based on clinical evaluation supported by neuroimaging findings, including cranial computed tomography and/or magnetic resonance imaging, and/or documentation by a neurologist or treating physician in the medical record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Ischemic, run by Marmara University Pendik Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke (time frame: 30 days (patient will be followed up 30 days based on their initial visit with dizziness. During the 30-day period, any subsequent visits to relevant specialities or the emergency department will be reviewed to assess for a stroke diagnosis.)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.