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临床试验/NCT02846259
NCT02846259Unknown不适用

The Clinical Benefit and Risk of Oral Aspirin for Patients Who Have Unruptured Intracranial Aneurysm Combined With Cerebral Ischemia

Beijing Tiantan Hospital1 个研究点 分布在 1 个国家目标入组 2,135 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
2,135
试验地点
1
主要终点
Aneurysm rupture hemorrhage

研究概览

简要总结

The first purpose of this study is to find out the clinical benefit and risk of oral aspirin for unruptured intracranial aneurysm (small than 7mm) combined with cerebral ischemia in patients in the real world.

The second purpose of this study is to get the prediction model of aneurysm's rupture in patients who has unruptured intracranial aneurysm (small than 7mm) combined with cerebral ischemia , and find out who is suitable for oral aspirin.

详细描述

The investigators try to collect the information of the patients have unruptured intracranial aneurysm combined with cerebral ischemia when oral aspirin.The characteristics of this study are large sample, multi center and prospective.In the real world, more and more patients are checked out unruptured intracranial aneurysm combined with cerebral ischemia.The investigators can collect the information such as how they use aspirin (dose, frequency, duration of treatment), demographic information, past history, daily life habits, morphological characteristics of the aneurysm, how they use other antithrombotic drugs.The investigators will record whether the aneurysm ruptured and have hemorrhage, ischemic stroke, death, changes in the morphology of aneurysm, MRI permeability image index changes. Finally the investigators will get the clinical benefits and risks of using aspirin and build the prediction model of rupture and hemorrhage for aneurysm, find out who is suitable for oral aspirin.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • has the diagnosis of unruptured intracranial aneurysm (using the CTA/DSA,smaller than 7mm)
  • has the history of TIA or any other diseases of cerebral ischemia
  • older than 18 years old
  • sign the informed consent

排除标准

  • has the history of intracranial aneurysm rupture hemorrhage or has more than one aneurysm untreated
  • has a family history of intracranial aneurysm
  • has AVM,MMD, intracranial tumor, hydrocephalus or intracranial hemorrhage
  • refuse to sign the informed consent
  • allergic to contrast medium

结局指标

主要结局

Aneurysm rupture hemorrhage

时间窗: 2 years during the follow-up period

Aneurysm subarachnoid hemorrhage without trauma

次要结局

  • TIA(2 years during the follow-up period)
  • Aneurysm changing(2 years during the follow-up period)
  • dead(2 years during the follow-up period)

研究者

发起方
Beijing Tiantan Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Yong Cao

principal

Beijing Tiantan Hospital

研究点 (1)

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