Micro-embolic Signals Detection With Transcranial HOLter in Acute Ischemic STroke: Yield in the Etiologic woR-kup
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 244
- 试验地点
- 2
- 主要终点
- Pattern of Microembolic signals (MES) recorded by Transcranial-holter monitoring and interpreted by an observer (index test)
研究概览
简要总结
In acute ischemic stroke, the identification of an etiology is of major importance to prevent recurrence by providing the best treatment. Because of numerous possible underlying etiologies, the etiological work-up of ischemic stroke includes a wide range of diagnostic tests, which can be invasive, long and expensive. Moreover, many patients receive a diagnosis of undetermined stroke even after all available diagnosis tests are done, precluding optimal treatment.
详细描述
Asymptomatic MES detected by transcranial doppler have been reported in patient with ischemic stroke. It has been previously demonstrated that MES predict stroke recurrence and that the frequency of MES depends on stroke etiology. However, the pattern of MES has never been correlated to stroke etiology. Transcranial-holter is a novel ambulatory system which allows prolonged recording (up to 4 hours) leading to an increased detection of MES.
Therefore, transcranial holter with an 4 hour-recording will be performed for consecutive eligible patients hospitalized in our stroke care unit. During the recording, the patient will be able to continue their usual activities (eating, walking, speaking and sleeping).
All the included patients will have a classical follow-up at 3, 6 months and 12 months. The neurologist, blinded to the results of transcranial-holter, will have to prescribe and analyze the results of diagnostic tests to identify stroke etiology. Stroke etiology will be established according to the ASCOD classification. Questioning and neurological exam (NIHSS score) will be performed looking for potential recurrent stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Ischemic stroke in the middle cerebral artery territory
- •Acute ischemic stroke within the 7 first days from the onset of the symptoms
- •Patient hospitalized in our stroke care unit
- •Man or woman older than 18 years
- •Patient affiliated to a social security system
- •Free Consent, informed writing signed by the participant or the person of confidence and the investigator (no later than the day of inclusion and before any examination required by research)
排除标准
- •Transient ischemic stroke
- •Ischemic stroke in the vertebro-basilar or anterior cerebral artery territory.
- •Proximal middle cerebral artery occlusion leading to the impossibility of recording
- •Patient who could not express his consent
- •Patient under guardianship or judicial protection
- •Pregnant or breastfeeding woman
- •Emergency situation
- •Life expectancy under 6 months
- •Exclusion criteria (after inclusion) :
- •Absent of bilateral Acoustic window
- •Analyzable Recording <30min
研究组 & 干预措施
Transcranial-holter monitoring
Transcranial doppler in patient with ischemic stroke
干预措施: Transcranial-holter monitoring (Device)
结局指标
主要结局
Pattern of Microembolic signals (MES) recorded by Transcranial-holter monitoring and interpreted by an observer (index test)
时间窗: Day 0 (inclusion)
Microembolic signals (MES) will be recorded using Transcranial-holter monitoring (index test) for 4 hours at the acute phase of ischemic stroke. The pattern will be described (frequency, laterality) by the observer interpreting recordings, blinded to stroke etiology as established by the reference standard.
Etiology of ischemic stroke according to ASCOD phenotyping (A: atherosclerosis; S: small-vessel disease; C: cardiac pathology; O: other causes D: dissection) (reference standard)
时间窗: Month 12
Etiologic work-up of ischemic stroke will result in ASCOD classification (reference standard) of etiology. Work-up and classification will be established blind to the pattern of microembolic signals recordede by Transcranial-holter monitoring (index test)
次要结局
- Stroke recurrence(Month 12)
- Actual duration of Transcranial-holter monitoring recording(Day 0 (inclusion))