NCT05623943已完成不适用
Comparison of Cerebral Artery Pressure Gradient and Cerebral Blood Flow Measured by Arterial Spin Labeling
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- The relevance between intravascular pressure gradients and CBF
研究概览
简要总结
The goal of this observational study is to explore the ability of intravascular pressure gradients to identify hemodynamic disturbance in patients with intracranial atherosclerotic diseases (ICAS). The main questions that aim to answer are:
- The correlation between intravascular pressure gradient and cerebral blood flow (CBF)
- The threshold for intravascular pressure gradients to predict hemodynamic disturbance in ICAS
Patients will undergo intravascular pressure measurement and arterial spin labeling (ASL) for CBF during pre- and post-operation respectively.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 40 years or older.
- •Patients with transient ischemic attack (TIA) or nondisabling ischemic stroke caused by a focal ICAS lesion located in intracranial anterior circulation (vertebral artery, basilar artery or intracranial internal carotid artery and their major branches).
- •50% to 99% stenosis (calculated by modified WASID method) of responsible arterial occlusion, confirmed by digital subtraction angiography (DSA).
- •Informed of the study protocol and objectives.
排除标准
- •Non-atherosclerotic MCA stenosis
- •Combined with moderate or severe stenosis of other extracranial and intracranial arteries
- •Previous endovascular treatment or surgery for cerebrovascular diseases
- •Large cerebral infarction (more than 1/2 MCA perfusion area)
- •Combined with other neurological diseases, such as aneurysm, arteriovenous malformation, tumor, hydrocephalus, cerebral trauma, cerebral hemorrhage, multiple sclerosis, epilepsy and intracranial infection.
- •Vascular abnormality or stunting, resulting in the impossibility of endovascular intervention
- •Liver and kidney dysfunction, or severe allergy to the contrast agent
- •Severe coagulation dysfunction
- •Pregnancy or in the preparation for pregnancy
- •Patients who cannot tolerate or do not allow MR screening, including metal implanting and claustrophobia
- •Patients with severe dementia or mental disorders, who cannot cooperate with examination
结局指标
主要结局
The relevance between intravascular pressure gradients and CBF
时间窗: Post-operation, an average of 3 days
Patients will be divided into 2 groups according to whether they have hemodynamic disorders before operation and improve after operation. Fractional flow reserve (FFR) measurement will be analyzed in each group.
次要结局
- Any stroke or death in short term.(30±5 days)
- The difference of FFR between pre- and post-operation(Baseline and Post-operation, an average of 3 days)
- The difference of ASL-CBF between pre- and post-operation(Baseline and Post-operation, an average of 3 days)
- Procedure-related complications(30±5 days)
研究者
研究点 (1)
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