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临床试验/NCT00997698
NCT00997698Unknown不适用

Imaging Epidemiological Investigation of Intracranial Aneurysms and the Prospective Study of Risk Factors:Assessment of MR Imaging Trail

Second Military Medical University1 个研究点 分布在 1 个国家目标入组 4,000 人开始时间: 2009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
4,000
试验地点
1
主要终点
Intracranial aneurysms identified by CE-MRA

研究概览

简要总结

This is a prospective observational registry with intent to detect the prevalence of intracranial aneurysms with contrast-enhanced MR angiography (CE-MRA) at 1.5T, and to determine the risk factors such as high blood pressure and cigarette smoking relating to intracranial aneurysms.

详细描述

Intracranial aneurysms are common and have been reported increased incidence rate because of the widespread use of high-resolution imaging techniques. They are clinically important because of the life-threatening rupture and hemorrhage. Early detection and diagnosis is the key of treatment. Contrast-enhanced MR angiography (CE-MRA), as a simple, sensitivity and noninvasive method, is playing an important role in Vascular Imaging. CE-MRA has been an accuracy modality for intracranial aneurysm at most centers and proved the high sensitivity and accuracy comparing with DSA. Therefore, we use CE-MRA at 1.5T as a tool of epidemiological investigation of intracranial aneurysms.

In retrospective analysis, conventional risk factors for intracranial aneurysms include hypertension, hyperlipidemia, diabetes mellitus (DM), smoking history, and family history, etc. However, retrospective analysis probably gives an underestimation or overestimation of the actual results. Prospective analysis will get accurate data on the risk factors relating to intracranial aneurysms

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
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 20 to 80 years
  • Willing to undergo study procedures
  • Who are fully informed about the study and have signed the informed consent form

排除标准

  • History of intracranial aneurysm
  • History of intracranial tumor
  • History of cerebral infarction
  • Acute stroke
  • Require emergency treatment
  • Contraindication for MRI examination
  • Severely impaired renal functions
  • Known anaphylactic reaction to MR contrast media
  • Pregnancy or nursing

结局指标

主要结局

Intracranial aneurysms identified by CE-MRA

时间窗: 24 months

次要结局

  • Statistical analysis of the prospective factors which contribute to the development of intracranial aneurysms(6 months after the study)

研究者

发起方
Second Military Medical University
申办方类型
Other

研究点 (1)

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