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临床试验/NCT06564129
NCT06564129尚未招募不适用

Characteristics and Prehospital Triage of Anterior Large Vessel Occlusion Stroke Based on EEG

Xuanwu Hospital, Beijing1 个研究点 分布在 1 个国家目标入组 1,194 人开始时间: 2024年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,194
试验地点
1
主要终点
Saline electrode EEG characteristics: area under the ROC curve for theta/alpha ratio;

研究概览

简要总结

This study is designed to evaluate the accuracy of saline electrode EEG in the prehospital diagnosis of LVO-a stroke.

详细描述

This is a multicenter, prospective, observational study,which will screen a total of 1194 patients in the participating centers during the period of June 1, 2024-December 31, 2025, and record single scalp EEG signals with eyes open at rest in the lying position of the patients using a non-invasive EEG acquisition device, and collect clinical data.

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

  • Phase I.1.Acute ischemic stroke caused by occlusion of the anterior circulation (intracranial origin of the internal carotid artery or proximal middle cerebral artery (M1/M2)) confirmed by CTA, MRA or DSA (diagnosis in accordance with the "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023");
  • Patient age ≥18 years;3: Last normal time to EEG acquisition time ≤ 72 hours;4: Signed informed consent.
  • Phase II-III
  • Diagnosed by a healthcare professional as a suspected acute stroke patient or a known acute stroke patient
  • Patient age ≥18 years
  • Last normal time to EEG acquisition time ≤ 24 hours
  • Signed informed consent

排除标准

  • Wounds in the area of electrode cap placement or active infection in the scalp;
  • Patients who do not cooperate with the EEG examination.

结局指标

主要结局

Saline electrode EEG characteristics: area under the ROC curve for theta/alpha ratio;

时间窗: 24 hours

Accuracy of theta/alpha ratio of electroencephalographic features for the diagnosis of large vessel occlusion Accuracy of theta/alpha ratio of electroencephalographic features for the diagnosis of anterior large vessel occlusion stroke

次要结局

  • Other EEG features including relative δ, θ, α power, δ/α ratio, δ+θ/α+β ratio, pdBSI, and WPLI diagnostic accuracy for LVO-a;(24 hours)
  • Development of one or more new algorithms for optimal diagnosis of LVO-a based on EEG data(24 hours)
  • Logic and technical feasibility of saline electrode EEG in ambulance for suspected stroke patients by paramedics;(24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Junwei Hao, MD

Characteristics and prehospital triage of anterior large vessel occlusion stroke based on EEG

Xuanwu Hospital, Beijing

研究点 (1)

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