跳至主要内容
临床试验/NCT05608122
NCT05608122已完成不适用

Establishment of Online Registration Platform for Unruptured Intracranial Aneurysms Based on Regional Medical Centers in China and Population Follow-up Study (Phase Ⅱ)

Beijing Tiantan Hospital1 个研究点 分布在 1 个国家目标入组 3,740 人开始时间: 2022年10月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3,740
试验地点
1
主要终点
Aneurysm rupture

研究概览

简要总结

Intracranial aneurysm is the main cause of subarachnoid hemorrhage, and the incidence of subarachnoid hemorrhage in Chinese population is about 5%. The intervention of unruptured intracranial aneurysms is controversial because of its great harm after natural rupture and bleeding, and about a quarter of patients still have poor prognosis through existing invasive treatment methods. How to accurately determine the instability risk of unruptured intracranial aneurysms is the key to resolve this controversy.

In previous studies, the stability of intracranial aneurysms involves many characteristics, and the sample size is small. Most of them are retrospective studies and studies on the status after change (rupture/growth). Therefore, the relevant risk factors are not clear at present, and there is still a lack of reliable prediction model. Based on the above facts, this study proposed based on the national hundred regional medical institutions set up the network registration platform of unruptured intracranial aneurysms, real time and openness of Internet, through the way of case resource sharing build unruptured intracranial aneurysm queue, collecting clinical characteristics, imaging features, hemodynamic detection of biological samples and the results of the analysis data, And observe them for two years. The artificial intelligence platform of Tonglian Medical Health was used to integrate and analyze and learn all the data, and then the risk factors related to the stability of intracranial aneurysms within two years were obtained, and the stability prediction model of unruptured intracranial aneurysms was constructed. This study will build the largest network registration platform and population follow-up cohort of unruptured intracranial aneurysms in China, and put forward a prediction model for the stability of unruptured intracranial aneurysms by integrating the multi-dimensional factors of intracranial aneurysms, so as to provide a powerful auxiliary judgment tool for the clinical decision-making of this disease.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-75 years old;
  • At least one unruptured intracranial aneurysm was found by CTA;
  • No relevant symptoms, receiving non-operative and conservative observation treatment;
  • Signing the informed consent.

排除标准

  • Other cerebrovascular structural lesions (such as cerebrovascular malformation and arteriovenous fistula) or craniocerebral tumors;
  • Fusiform or dissecting aneurysms;
  • Traumatic, mycotic and atrial myxoma associated aneurysms;
  • Suffering from systemic connective tissue diseases, such as polycystic kidney disease;
  • Expectant survival of no more than 3 years due to other diseases or poor general conditions;
  • Patients refuse to follow up or cannot communicate with them due to mental diseases;
  • Pregnant women or participating in other aneurysm related studies.

结局指标

主要结局

Aneurysm rupture

时间窗: 2 years

次要结局

  • Aneurysm growth(2 years)

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

Wang Shuo

Department of neurosurgery

Beijing Tiantan Hospital

研究点 (1)

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