Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06641050
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-11
Brief Title:
Validation of TriAGE for Predicting Stroke Risk in ED Patients Presenting With Dizziness
Sponsor:
None
Organization:
None
Study Overview
Official Title:
External Validation of the TriAGE Score for Predicting Cerebrovascular Disease Risk in Patients Presenting With Dizziness in the Emergency Department
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Ischemic cerebrovascular diseases originating from the brains 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 24 of ED visits involved dizziness with 368 of those patients being hospitalized due to central neurological events
Cerebrovascular events CVEs involving the brains 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 84 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 775 95 CI 728-818 and specificity 721 95 CI 641-792 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 scores 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
Cerebrovascular events CVEs involving the brains 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 84 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 775 95 CI 728-818 and specificity 721 95 CI 641-792 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 scores 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None