跳至主要内容
临床试验/NCT06641050
NCT06641050已完成不适用

External Validation of the TriAGE+ Score for Predicting Cerebrovascular Disease Risk in Patients Presenting With Dizziness in the Emergency Department

Marmara University Pendik Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 818 人开始时间: 2024年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
818
试验地点
1
主要终点
Stroke

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

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.

干预措施: TRIAGE+ score assessment (Other)

结局指标

主要结局

Stroke

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Marmara University Pendik Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Emre Kudu

Principal Investigator

Marmara University Pendik Training and Research Hospital

研究点 (1)

Loading locations...

相似试验

Validation of TriAGE+ for Predicting Stroke Risk in... | 临床试验