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临床试验/NCT02361411
NCT02361411Unknown不适用

A Research of the Methods of Etiological Diagnosis of Cerebral Amyloid Angiopathy

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2015年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,000
试验地点
1
主要终点
apolipoprotein E gene polymorphism

研究概览

简要总结

The purpose of this study is to

  1. Early identify patients based on clinical manifestation, imaging, gene and histology, explore diagnostic tools
  2. get gene repertoire of Chinese
  3. Build a cerebral amyloid angiopathy (CAA) prospective cohorts, observing the disease history, and exploring prognostic factors of hemorrhage in CAA patients

详细描述

We recruited consecutive patients with intracerebral hemorrhage(ICH). Clinical data and the results of laboratory tests and CT will be assessed and recorded. All the subjects will get gene tests including many genes related with Aβ and small vessel disease (Next-generation sequencing and target enrichment system) .

The result of the MRI Scans including cerebral microbleeds(CMBs)、Cortical superficial siderosis(cSS), white matter change(WMC) and enlarged perivascular spaces (EPVS) will be assessed using scales. Ocular fundus exams such as funduscopy and imaging will be used to assess multiple dot and blot hemorrhages and microaneurysms by ophthalmologist. Mini-mental state examination(MMSE) will be used to assess the cognitive function.

Patients who need operation on the hematoma for the treatment will accept a brain tissue pathological exams According to this, a prospective cohort of CAA patients based on clinical manifestation, imaging, gene and histology will be built, and diagnostic tools such as gene and MRI results, etc will be explored. And we will get gene repertoire of Chinese patient with ICH.

Then, the subjects will be followed up on 30-day, 3-month, 6-month, and 1-year.The patients' clinical outcome will be assessed , and the results of laboratory tests and therapy will be recorded. Prognostic factors of patients with CAA related ICH will be explored.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • ①diagnosed wiht spontaneous cerebral hemorrhage after the head CT.
  • ② the patients and their family members agreed to participate in this study.

排除标准

  • ①cerebral hemorrhage caused by traumatic, cerebral infarction, tumor and arteriovenous malformation.
  • ②patients who can not provide reliable information or are considered unsuitable for the study.

结局指标

主要结局

apolipoprotein E gene polymorphism

时间窗: baseline

次要结局

  • CMBs were evaluated using the Microbleed Anatomical Rating Scale (MARS)(baseline)
  • a composite outcome including multiple dot and blot hemorrhages and microaneurysms of the fundus(baseline)
  • recurrence of cerebral hemorrhage(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fan Dongsheng

Chairman of the department of neurolog of Peking University Third Hospital

Peking University Third Hospital

研究点 (1)

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