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临床试验/NCT05619068
NCT05619068招募中不适用

Imaging Investigation on the Evolution and Prognosis of Moyamoya Disease

Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
300
试验地点
1
主要终点
Rate of Cognitive decline

研究概览

简要总结

To investigate the evolution of imaging appearances and cognitive function of Moyamoya disease (MMD) and to establish a prognosis evaluation system based on imaging biomarkers in MMD. The study may be helpful to optimize and improve the diagnosis and pretreatment assessment of MMD, and provide an important theoretical supplement to the existing guidelines for the management of MMD.

详细描述

Moyamoya disease (MMD) is a chronic progressive cerebrovascular disease of unknown etiology. It is characterized by chronic progressive stenosis or occlusion of bilateral internal carotid arteries and abnormal puff vessels at the base of the brain. MMD is one of the important causes of cerebrovascular accident in young and middle-aged people, which leads to about 22% of stroke. With the development of neurosurgery, revascularization can effectively reduce the risk of stroke and other cerebrovascular accidents by increasing cerebral perfusion. Therefore, this project is expected to improve the diagnosis and pretreatment assessment of MMD from the traditional level of symptomatology to the level of brain cognitive function through new imaging methods and clinical approaches. The study of cognitive function changes in follow-up period or after revascularization, which is of great scientific significance for understanding the plasticity of cognitive function under different cerebral perfusion conditions, will also be conducted.

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
10 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with MMD: Conventional angiography or MRI examination conforms to the Guidelines for Diagnosis and Treatment of MMD (Neurol Med Chir (Tokyo) 52, 245-266, 2012), It is characterized by stenosis or occlusion of the end of the internal carotid artery, anterior cerebral artery and/or the beginning of the middle cerebral artery of unknown cause, accompanied by dilatation of the perforating artery at the base of the brain or of capillaries on the surface of the brain, i.e., the formation of smoke vessels. Sign the informed consent. Older than 10 and younger than
  • The education level of patients reached primary school or above (years of education ≥6).

排除标准

  • Patients with massive cerebral infarction, multiple paraventricular ischemic foci, or significantly enlarged ventricular hydrocephalus after intracerebral hemorrhage. Patients with vascular diseases caused by immune system disease. Patients can not cooperate to complete the cognitive function test. There are other neuropsychiatric diseases that affect cognitive function (such as Alzheimer's disease, Parkinson's disease, depression, anxiety disorder, cerebral hemorrhage, hydrocephalus, craniocerebral trauma, etc.). Patients with contraindications of magnetic resonance examination (patients with pacemakers, nerve stimulators, artificial metal heart valves and other metal foreign bodies) or unable to complete image collection.

结局指标

主要结局

Rate of Cognitive decline

时间窗: 1-5 years

Cognitive decline was defined as decreasing in any of the scale below. Choice reaction time was used as the baseline condition and the index of movement ability. Nonverbal matrix reasoning was used to assess general intelligence and reasoning ability. The Eight-item Interview to Differentiate Aging and Dementia questionnaire was used to determine the degree of cognitive decline in daily life. The mental rotation was used to evaluate the visual-spatial ability. Verbal working memory was used to measure working memory capacity. All cognitive assessment were tested using an Online Psychological Experimental System.

次要结局

  • Changes of functional connectivity(1-5 years)
  • Changes of perfusion status(1-5 years)

研究者

发起方
Chinese PLA General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xin Lou

Chairman

Chinese PLA General Hospital

研究点 (1)

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