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临床试验/NCT05189041
NCT05189041终止不适用

Determination of the Aneurysm Vulnerability Index by Stimulation and Medical Imaging

University Hospital, Montpellier2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
45
试验地点
2
主要终点
Quantify the aneurysmal pulsation in functional MRI

研究概览

简要总结

Stroke is the leading cause of disability in France with 130,000 cases per year, 20% of strokes being hemorrhagic, with a majority of intracranial aneurysm rupture (80%). Each year, 6000 meningeal hemorrhages (MHA) caused by cerebral aneurysm rupture are reported in France: 40% of patients die within the first month and 30% are left with severe and permanent disability. Intracranial aneurysms are present in 2 to 6% of the population and only about 0.5% of them will rupture. Given the human and economic costs associated with this disease, systematic medical screening for intracranial aneurysms could be useful. However, the operative risk of endovascular treatment remains non-zero (around 1%) and could be proposed only to a selected population of aneurysms at risk of rupture. The absence of diagnostic criteria for aneurysmal vulnerability does not allow for the moment to consider screening for this disease, which continues to strike without warning a young and active population.

Nevertheless, access to brain imaging allows the detection of an increasing number of intracranial aneurysms. The question of preventive treatment then arises and is still a difficult point discussed by neurosurgeons / neurointerventionists based on general epidemiological data difficult to apply to an individual.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age limits to > 18 years
  • Collection of the informed consent (patient or legal representant)
  • Affiliation or recipient with the mode of social security
  • Groupe anévrysme rompu
  • Patient porteur d'un anévrysme rompu
  • Groupe anévrysme non rompu
  • Patient porteur d'un anévrysme non rompu

排除标准

  • Subject presenting contraindications in MRI (Ferromagnetic foreign bodies, pace-maker ...)
  • Claustrophobia
  • Women pregnant or Breast-feeding
  • Patient participating in an other study
  • Patient have participated in a study in the 3 months before the inclusion
  • In period of exclusion relative to another protocol
  • Person with majority age protected by the law (supervision or trusteeship).
  • Patient not reading the french language
  • Patient or representant for whom it impossible to give accurate informations

结局指标

主要结局

Quantify the aneurysmal pulsation in functional MRI

时间窗: 1 day

Quantify the aneurysmal pulsation in functional MRI on the patient with Ruptured Cerebral Aneurysm or Non ruptured Aneurysm

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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