Stroke Imaging Package Study of Intracranial Atherosclerosis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 550
- 试验地点
- 38
- 主要终点
- Number of Participants with stroke recurrence
研究概览
简要总结
A prospective, multicenter, cohort study to explore the stroke mechanisms of symptomatic intracranial atherosclerosis, the dynamic changes under aggressive medical treatment and their associations with clinical events using conventional MRI sequences plus high-resolution magnetic resonance (HR-MRI).
详细描述
- First-ever stroke patients attributed to intracranial artery stenosis (> 50% or occlusion) within 7 days after onset will be prospectively enrolled in our study and undergo new imaging technique package assessment at baseline.
- The imaging technique package includes conventional cranial MRI （T1,T2,T2 FLAIR,DWI), cranial magnetic resonance angiography (MRA),high-resolution magnetic resonance (HR-MRI) and susceptibility weighted imaging (SWI) or T2*-weighted imaging.
- Enrolled patients are recommended to receive aggressive medical management consisted of Aspirin (100 mg daily) and Clopidogrel (75 mg daily) for 3 months and Rosuvastatin (20mg daily) for at least 6 months as well as traditional risk factors management.
- Patients were followed up for mRS score, stroke recurrence, medication compliance and laboratory examination including blood routine tests, liver functions and creatine kinase et al at 3 months, 6 months and 12 months after stroke onset. Additionally, patients are required to retake new HRMRI imaging of brain at 6 months.Remote patient education by We-Chat will be performed.
- Our study aims to explore the stroke mechanisms of symptomatic intracranial atherosclerosis, the dynamic changes under aggressive medical treatment and their associations with clinical events using conventional MRI sequences plus HR-MRI.
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
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 35-80 years old
- •First-ever stroke patients confirmed by diffusion weighted imaging (DWI) attributed to intracranial artery stenosis (> 50%) within 7 days after onset.
- •Patients with stable vital signs.
- •Patients who have underwent thrombolytic/intravascular therapy are allowed to enroll in the study.
排除标准
- •Patients with > 50% ipsilateral carotid artery stenosis, cardiac embolism ,and any other stroke etiologies such as vasculitis, dissection or other causes.
- •Patients with absolute/relative contraindication to MRI (including but not confined to metal in the body and claustrophobia).
- •Patients who cannot comply with MRI exam.
- •Patients who decline the consent.
研究组 & 干预措施
Intracranial Atherosclerosis
First-ever stroke patients attributed to intracranial artery stenosis (> 50% or occlusion) who receive aggressive medical management
干预措施: aggressive medical management (Drug)
结局指标
主要结局
Number of Participants with stroke recurrence
时间窗: 12 months after stroke onset
stroke recurrence with new lesions on DWI
poor functional outcome
时间窗: 90 day after stroke onset
The Rankin Score runs from 0-6, running from perfect health without symptoms to death. mRS 0-2 are defined as favorable outcomes while mRS 3-6 as unfavorable outcomes.0 - No symptoms.1 - No significant disability. Able to carry out all usual activities, despite some symptoms.2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.3 - Moderate disability. Requires some help, but able to walk unassisted.4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.6 - Dead.
Evolution of intracranial atherosclerosis burden
时间窗: 6 months after stroke onset
Changes of plaque and thrombus volume on HR-MRI images at the admission and the follow-up
次要结局
- Number of Participants with Death due to Heart Disease, Cerebravascular Disease or Other Vascular Etiology(12 months after stroke onset)
研究者
Wei-Hai Xu
Professor
Peking Union Medical College Hospital