Cognitive Decline and Underlying Mechanisms in Symptomatic Intracranial Atherosclerotic Stenosis Patients: A Multicenter Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The changes in Memory
研究概览
简要总结
The purpose of this study is to explore the mechanism of cognitive impairment in patients with symptomatic intracranial atherosclerotic stenosis (ICAS), and further plans to explore the impact of different treatment options on cognitive function in symptomatic ICAS patients.
详细描述
All participants underwent a medical evaluation that included routine laboratory studies before and after 3-month and 1-year follow-up. Upon meeting the inclusion criteria and providing informed consent, each participant will complete a battery measure of neuropsychological tests, blood sample collection, and magnetic resonance imaging scan after enrollment and after 3-month and 1-year follow-up.
About 100 participants were included in this study. A series of neuropsychological tests were obtained by a trained investigator to assess. The tests include the evaluation of global cognitive function and multiple individual cognitive domains. The various tasks and questionnaires to measure cognition function including Montreal Cognitive Assessment (MoCA), Mini Mental State Examination (MMSE), Chinese Auditory Verbal Learning Test (CAVLT), Digital Span Test (DST), , Stroop color test (Stroop test), Color trail test (CTT), Clock Drawing Test (CDT), Verbal Fluency Test (VFT), etc., at the same time, the investigators also pay attention to the evaluation of participants' emotions by Hamilton Anxiety Scale (HAMA), Hamilton Depression Scale (HAMD). Furthermore, the memory and the occurrence of cerebrovascular events as the primary outcome measure, this study focused on the multidimensional cognitive function and cerebrovascular events of patients with symptomatic ICAS. Blood sample will be collected for biological multiomics research. The patients will receive a magnetic resonance imaging scan in multi-modalities.
After 3-month and 1-year follow-up, the participants will be interviewed to obtain the same assessments, blood sample and magnetic resonance imaging scan in multi-modalities as before.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years
- •Severe stenosis (≥70%-99%) of atherosclerotic internal carotid artery (C6 segment, C7 segment) or middle cerebral artery (M1 segment) confirmed by digital subtraction angiography (DSA) or at least two of the following non-invasive examinations: magnetic resonance angiography (MRA), computed tomography angiography (CTA), or transcranial Doppler (TCD)
- •Transient ischemic attack (TIA) or minor stroke (National Institute of Health Stroke Scale [NIHSS] score ≤ 4 points)
- •Right-handed and able to cooperate in neuropsychological tests
- •At least 14 days post-onset of cerebral infarction or TIA
- •Signed informed consent
排除标准
- •Other diseases that affect cognitive function, such as cerebral hemorrhage, •Parkinson's disease, neurosyphilis, dementia, tumors, etc.
- •Right upper limb hemiplegia, aphasia, visual field defects, or visual impairments
- •More than 50% stenosis of the extracranial internal carotid artery, the vertebral artery, or the basilar artery
- •Vasculitis, moyamoya disease, and cardiogenic stroke
- •Previous history of head and neck stent implantation, carotid endarterectomy, aneurysm embolization, or other intracranial surgeries
研究组 & 干预措施
Surgery Group
Symptomatic intracranial stenosis patients who receive endovascular therapy combined with standard medical treatment
干预措施: Endovascular therapy,Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin (Procedure)
Medical group
Symptomatic intracranial stenosis patients who receive standard medical treatment without endovascular therapy
干预措施: Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin (Drug)
结局指标
主要结局
The changes in Memory
时间窗: baseline, 3-month and 1-year follow-up
The changes in Memory function will constitute one of the main indicators of research results, which will be used to evaluate the follow-up results of the standard treatment regimen. The investigators will use the Chinese Auditory Verbal Learning Test (CAVLT) to evaluate the immediate, delayed and recognition memory of patients with symptomatic ICAS to evaluate the immediate, delayed and recognition memory of patients with ICAS.
Occurrence of ischemic cerebrovascular events
时间窗: baseline, 3-month and 1-year follow-up
The changes in occurrence of ischemic cerebrovascular events constitute another major indicator of research result. The new responsible cerebrovascular events during the follow-up period are also the clinical information the investigators pay attention to, including transient ischemic attack (TIA) and stroke.
次要结局
- The Stroop Color Test(baseline, 3-month and 1-year follow-up)
- HAMD (Hamilton Depression Scale)(baseline, 3-month and 1-year follow-up)
- DST (Digital Span Test; Forward and Backward)(baseline, 3-month and 1-year follow-up)
- CTT (Color Trail Test)(baseline, 3-month and 1-year follow-up)
- Ultrasound measures-IMT (intima-media thickness)(baseline, 3-month and 1-year follow-up)
- MMSE (Mini Mental State Examination)(baseline, 3-month and 1-year follow-up)
- HAMA (Hamilton Anxiety Scale)(baseline, 3-month and 1-year follow-up)
- MRI measures-3D pCASL images(baseline, 3-month and 1-year follow-up)
- MoCA (Montreal Cognitive Assessment)(baseline, 3-month and 1-year follow-up)
- CDT (Clock drawing test)(baseline, 3-month and 1-year follow-up)
- VFT (Verbal Fluency Test)(baseline, 3-month and 1-year follow-up)
- MRI measure- resting state MRI images(baseline, 3-month and 1-year follow-up)
- Ultrasound measures-MCA-PI (middle cerebral artery-pulsatility index)(baseline, 3-month and 1-year follow-up)
- Blood Metabolomics measures-CRP (C-reactive protiein)(baseline, 3-month and 1-year follow-up)
- Blood Metabolomics measures-oxLDL(Oxidized low-density lipoprotein)(baseline, 3-month and 1-year follow-up)
- MRI measures-structural phase MRI images(baseline, 3-month and 1-year follow-up)
- Blood Metabolomics measures-miRNA/microRNA(baseline, 3-month and 1-year follow-up)
研究者
WANG KAI
Head of Neurology, Principal Investigator，Clinical Professor
Anhui Medical University