Revascularization Effect on CSVD Burden in Carotid Artery Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- The development of total brain small vessel disease burden in MRI
研究概览
简要总结
RECAS is a prospective cohort of 1,000 patients with carotid artery stenosis (CAS) and undergoing revascularization therapy or standard medication treatment alone. The goal of this study is to validate whether CAS revascularization when compared to standard medication treatment alone, can effectively reduce the progression of Cerebral small vessel disease (CSVD) burden, as well as improve the severity of retinal pathologies and cognitive impairment. Therefore, Patients aged ≥ 40 years have more than 50% stenosis in unilateral carotid artery and sign informed consent will be recruited. In this study, patients will be asked to undergo Computed Tomography Angiography (CTA)/ Digital Subtraction Angiography (DSA), Computed Tomography Perfusion (CTP),multimodal Magnetic Resonance Imaging (MRI), Optical Coherence Tomography Angiography (OCTA) and neuropsychological testing. Estimated follow-up can be up to 10 years.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥ 40 years.
- •≥ 50% stenosis in unilateral carotid artery.
- •Sign informed consent.
排除标准
- •Previous history of major head trauma and any intracranial surgery
- •Intracranial abnormalities, such as intracerebral hemorrhage, subarachnoid hemorrhage, and other space occupying lesions
- •Extrapyramidal symptoms or mental illness which may affect neuropsychological measurement.
- •Severe loss of vision, hearing, or communicative ability.
研究组 & 干预措施
Individuals accepted CAS
Procedure: CAS and Standard medical treatment.
Other:
- Neuropsychological testing.
- Multimodal CT: included NCCT+CTP and reconstructed 4D-CTA.
- Multimodal MRI included T1, T2-FLAIR, DWI, DTI, SWI, fMRI.
- Optical coherence tomography angiography.
干预措施: carotid artery stenting (Procedure)
Individuals accepted CAS
Procedure: CAS and Standard medical treatment.
Other:
- Neuropsychological testing.
- Multimodal CT: included NCCT+CTP and reconstructed 4D-CTA.
- Multimodal MRI included T1, T2-FLAIR, DWI, DTI, SWI, fMRI.
- Optical coherence tomography angiography.
干预措施: drug therapy (Drug)
Individuals accepted standard medical treatment alone.
Procedure: Standard medical treatment alone.
Other:
- Neuropsychological testing.
- Multimodal CT: included NCCT+CTP and reconstructed 4D-CTA.
- Multimodal MRI includedT1, FLAIR, MRA, PWI and/or ASL, DTI, DKI, SWI, fMRI.
- Optical coherence tomography angiography.
干预措施: drug therapy (Drug)
结局指标
主要结局
The development of total brain small vessel disease burden in MRI
时间窗: baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.
Total brain small-vessel disease burden is used to assess the overall impact of CSVD, with a score range of 0-4 points.
次要结局
- Montreal Cognitive Assessment (MoCA) score(baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.)
- Vascular perfusion area(baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.)
- Number of Patients with cerebrovascular events, cardiovascular events or death(baseline,1-month,3-month,6-month,and every 1 year, follow-up time up to 10 years.)
- Mini-mental State Examination(MMSE) score(baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.)
- Macular fovea retinal thickness(baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.)
- Change of the volume of hypoperfusion (delay time>3s from baseline to follow-up CTP).(baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.)
- Stenosis percent(baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.)
- Retinal nerve fiber layer thickness(baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.)
- Blood flow density(baseline,3-month,6-month,and every 1 year, follow-up time up to 10 years.)