Effects of Medical Treatment of Intracranial Atherosclerotic Diseases Based on Magnetic Resonance Fractional Flow Reserve
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- The composite of ischemic stroke or death related to the qualifying artery territory
研究概览
简要总结
This multicenter prospective cohort study aims to compare the difference in the effects of medical treatment within 1 year between the two groups of ICAS patients divided hemodynamically by Magnetic Resonance Fractional Flow Reserve. PC MRA will be applied for FFR measurement. The primary outcome is the composite of ischemic stroke or death related to the qualifying artery territory for 1 year.
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged from 30 to 80 with symptomatic ICAS lesion in anterior circulation.
- •50% to 99% stenosis (in accordance with modified WASID method) confirmed by DSA, CTA or MRA.
- •mRS 0-2 points
- •Informed of the study protocol and objectives.
排除标准
- •Previous endovascular treatment or surgery for cerebrovascular diseases
- •Large cerebral infarction (more than 1/2 MCA perfusion area) according to MRI
- •Combined with other neurological diseases, such as aneurysm, arteriovenous malformation, tumor, hydrocephalus, cerebral trauma, cerebral hemorrhage, multiple sclerosis, epilepsy and intracranial infection.
- •Pregnancy or in the preparation for pregnancy
- •Patients who cannot tolerate or do not allow MR screening, including metal implanting and claustrophobia
- •Contraindication for antiplatelet drugs or statins
- •Patients with severe dementia or mental disorders, who cannot cooperate with examination
研究组 & 干预措施
Decompensated blood flow reserve
ICAS patients with decompensated cerebral blood flow reserve diagnosed by MR-FFR (FFR baseline≥0.81).
干预措施: Standard Medical Treatment on the basis of anti-platelet therapy (Drug)
Normal blood flow reserve
ICAS patients with normal cerebral blood flow reserve determined by MR-FFR (FFR baseline<0.81).
干预措施: Standard Medical Treatment on the basis of anti-platelet therapy (Drug)
结局指标
主要结局
The composite of ischemic stroke or death related to the qualifying artery territory
时间窗: 1 year
次要结局
- Functional evaluation(1 year)