Effect of Carotid Artery Stent on Evoked Cerebral Blood Oxygenation and Neurocognitive Functioning
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Change of cognitive function score
研究概览
简要总结
Cerebral hemodynamic compromise from internal carotid artery stenosis may be a cause of vascular cognitive impairment that is amenable to treatment by revascularization. The effect of carotid artery stent on evoked cerebral blood oxygenation and neurocognitive functioning will be evaluated by functional near-infrared spectroscopy. Carotid artery stent could benefit cerebral blood oxygenation after stent and improving neurocognitive functioning after 6 months.
详细描述
Patients with high grade internal carotid artery stenosis intended to carotid artery stent are brought to this study. Global cognitive function and evoked cerebral blood oxygenation are evaluated before and after stent, followed up at 6 months later. Mini-Mental State Examination(MMSE) and Montreal Cognitive Assessment (MoCA) are used for the global cognitive test. Evoked cerebral blood oxygenation is evaluated using functional near-infrared spectroscopy(fNIRS) through performing mental task( N-back task, Go/no go task, and verbal fluency task ). All the patients from different centers are conducted the test at the only main center by one doctor. The parameter of fNIRS and score of cognitive test of each patient are compared before and after stent.
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
- •35-80 years old
- •Severe carotid stenosis (MRA or CTA confirmed stenosis rate of 70% - 99%, NASCET standard)
- •Asymptomatic or mild stroke (NIHSS ≤ 3) or TIA
- •Agree to participate in the clinical trial and sign the informed consent
排除标准
- •Severe stenosis or occlusion of vertebrobasilar artery and other intracranial arteries (70% - 99%)
- •Left ventricular ejection fraction < 50% or heart failure
- •Other types of dementia have been diagnosed
- •Severe depression, mental illness, epilepsy
- •Not cooperating with cognitive task evaluation
结局指标
主要结局
Change of cognitive function score
时间窗: MMSE score at baseline, 6 months after revascularization. Change of the score is calculated.
Mini-mental State Examination (0-30 points), the higher the score, the better the cognitive function
次要结局
- Parameter of evoked cerebral blood oxygenation(Evoked cerebral blood oxygenation evaluated after stent immediately, 6 months later, compared with that at baseline.)
研究者
Yueqi Zhu
Principal Investigator
Shanghai Jiao Tong University Affiliated Sixth People's Hospital