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临床试验/NCT01031147
NCT01031147Unknown不适用

Detection of Intracranial Aneurysm With Non-enhanced, Three-dimensional Time-of-flight Magnetic Resonance Angiography(3D-TOF-MRA): a Prospective Comparison With Three-dimensional Reconstructed Digital Subtraction Angiography (3D RDSA)

Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2007年6月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
350
试验地点
1

研究概览

简要总结

The Chinese Cerebral Aneurysms Survey is a continuing prospective study to evaluate the effectiveness of unenhanced, three-dimensional time-of-flight magnetic resonance angiography (3D-TOF-MRA) with volume rendering (VR) at 3-T in the detection of intracranial aneurysms.

详细描述

Recent years,three-dimensional time-of-flight MRA (3D-TOF-MRA) has become a useful, contrast-free method for observing intracranial vessels and is widely utilized as a screening examination for intracranial aneurysms. The studies available in Medline show mixed results.Some of these studies just included MRI/MRA in the analysis, which have a high rate of false-positives and are unreliable, and some were lack of control (ruptured aneurysm), precise numbers of false-positive results, standard images process and review, or corroborative IADSA in some patients. Furthermore, most previous studies included small sample size with aneurysm detection at 0.5-T or 1.5-T MR. Thus, these results have been inconclusive because of certain pitfalls in these studies.

Since 2007, we have conducted a clinical study to objective detection of intracranial aneurysms in our routine diagnostic work-up of intracranial aneurysms by our neuroradiologists using a standard procedure with 3D-TOF-MRA with VR at 3T. The investigators want to establish the quality data to prospectively compare 3D-TOF-MRA with VR at 3T vs 3D-RDSA in the diagnosis of intracranial aneurysms in a largest cohort of patients and test it accuracy in screening for suspected patients

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

入选标准

  • Suspected or known intracranial aneurysms

排除标准

  • Patient's inability to cooperate
  • Chronic renal failure patients
  • Any patients with a contraindication to MRA examination, such as pacemaker, orbital metallic foreign body, coronary stent, etc.
  • Any patients with a contraindication to DSA examination, such as allergic to contrast medium, etc.

研究者

发起方
Shanghai Jiao Tong University School of Medicine
申办方类型
Other

研究点 (1)

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