跳至主要内容
临床试验/NCT06718075
NCT06718075招募中不适用

Canadian TIA Score Versus ABCD2 Score in Risk Stratification of Transient Ischemic Attack (TIA)

IRCCS Azienda Ospedaliero-Universitaria di Bologna1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
800
试验地点
1
主要终点
Occurrence of stroke or carotid revascularization

研究概览

简要总结

This study aims to evaluate the superiority of a clinical score (Canadian TIA score) compared to the currently more widely used score in clinical practice (ABCD2 score) in stratifying the risk of stroke or carotid revascularization following a transient ischemic attack at 7 days, and to assess its superiority at 90 days in a European population.

Patients with transient ischemic attack are at high risk of developing a subsequent stroke, especially in the short term. Identifying patients at greater risk would allow for optimized management to provide aggressive treatment within the first days following the event. All patients attending the Emergency Medicine department of this hospital will be enrolled over a consecutive 24-month period. Approximately 800 participants are expected to take part in this study.

At the time of admission to the Emergency Medicine department, the various prognostic scores relevant to the study will be completed, taking about one minute. At 7 and 90 days from the date of admission, the patient will be contacted by phone and will be administered a validated questionnaire (Questionnaire for Verifying Stroke-Free Status), which will take approximately one minute.

详细描述

Rationale: Patients with transient ischemic attack (TIA) are at high risk of developing a subsequent stroke, especially in the short term. Identifying patients at greater risk allows for optimized management to provide aggressive treatment in the early days following the event, a strategy that is not feasible for the entire patient cohort. Over time, several prognostic scores have been studied, among which the most widely used is the ABCD2 score; however, this score has not proven particularly reliable in distinguishing between low-risk and high-risk patients in prospective validation studies. More recently, the Canadian TIA score has been proposed, but it has only been validated in the Canadian population.

Study design: Patients with TIA attending the Emergency Department of IRCCS AOU di Bologna Policlinico di S.Orsola will be included, and they will be admitted to the Emergency Medicine department according to the currently implemented protocol. At the time of admission, the various prognostic scores relevant to the study (Canadian TIA score, ABCD2, and ABCD3) will be completed by the physician during the standard medical assessment. Patients will also be contacted by phone at 7 and 90 days.

The study is observational and non-interventional. Patients will be treated according to standard clinical practice based on the physician's judgment and the information provided in the Technical Data Sheet of each individual product for any concomitant therapies administered according to clinical practice.

Objectives: The study aims to evaluate the superiority of the Canadian TIA score compared to the ABCD2 score in stratifying the risk of stroke or carotid revascularization following TIA at 7 days, and to assess its superiority at 90 days in a European population. Additionally, secondary objectives will include evaluating the superiority of the Canadian score over the ABCD2 score in stratifying the risk of major cerebrovascular events following TIA at 7 and 90 days across different subpopulations (age < or ≥ 65 years; TIA etiology according to the TOAST classification) and assessing the superiority of the Canadian score compared to the ABCD2 score in stratifying the risk of major cerebrovascular events following TIA at both 7 and 90 days.

Outcomes: The primary outcome will be composite: the occurrence of stroke or carotid revascularization (endarterectomy or stenting) within 7 days of emergency department admission. Stroke will be defined as the sudden onset of neurological symptoms that persist for more than 24 hours or until death, in the absence of apparent non-vascular causes. A secondary outcome will be the occurrence of a stroke within 7 days of emergency department admission, regardless of carotid revascularization, and at 90 days. Outcomes will be assessed through electronic medical records and emergency department reports. All patients will be contacted at 7 and 90 days to evaluate any subsequent TIA or stroke using the validated questionnaire "Questionnaire for Verifying Stroke-Free Status."

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

入选标准

  • all patients presenting to the emergency department with a diagnosis of TIA
  • all adult patients
  • all patients who have signed the informed consent

排除标准

  • 未提供

结局指标

主要结局

Occurrence of stroke or carotid revascularization

时间窗: From the start of recruitment to the following 7 days

Occurrence of stroke or carotid revascularization (endarterectomy or stenting) within 7 days of emergency department admission. Stroke will be defined as the sudden onset of neurological symptoms that persist for more than 24 hours or until death, in the absence of apparent non-vascular causes."

次要结局

  • Occurrence of a stroke of emergency department admission, regardless of carotid revascularization(From the start of recruitment to the following 90 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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