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临床试验/NCT04115553
NCT04115553进行中(未招募)不适用

Assessment of Venous Drainage in Idiopathic Intracranial Hypertension

Centre Hospitalier Universitaire, Amiens2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年2月19日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
60
试验地点
2
主要终点
Ratio between jugular vein flow and total arterial brain flow.

研究概览

简要总结

Intracranial hypertension (IIH) is a disorder producing a syndrome of increased intracranial pressure secondary to a compressive intracranial lesion or said to be idiopathic. The most common symptoms are headaches, blindness, pulsatile tinnitus or papillary edema. There are many options for the treatment of IIH, especially neurosurgery (derivation of cerebrospinal fluid or stent placement). Currently, idiopathic IIH has no clear etiology but the hypothesis of sino-venous insufficiency is more and more recognized. The assumption of venous insufficiency has not been demonstrated so far. Therefore the investigators propose to demonstrate that cerebral venous drainage pathways are altered in adult patients with idiopathic intracranial hypertension in comparison to healthy individuals having normal circulation. Assessment will be performed using Magnetic Resonance Imaging which is part of the patient care.

详细描述

The investigator working hypothesis is an impairment of the cerebral venous drainage in IIH compared to the circulation observed in healthy volunteers considered as the reference. The research will focus on adult patients referred to the imaging department for intracranial hypertension assessment. MRI support is common for this type of request The reference will be established in a population of healthy volunteers for whom MRI blood flow measurements will be performed. In addition to the primary objective, the investigators assess the impact of IIH on CSF dynamics The study does not present any risk for the subject, any contraindication to MRI examination being respected. The subjects will undergo MRI examination including morphological and flow sequences without contrast injection. The flow sequences, in planes located at the C2-C3 and aqueductal levels, will be used to measure vascular flows (venous and arterial) and CSF oscillatory volumes. Image post-processing will be performed on a semi-automatic software allowing to extract fluid dynamics parameters.

研究设计

研究类型
Interventional
分配方式
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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age : >18 years old
  • adult patients referred to the imaging department for intracranial hypertension assessment
  • adult control subjects without history of cerebral or vascular pathology

排除标准

  • history of cerebral or vascular pathology for the control subjects
  • pregnant woman
  • claustrophobia
  • major obesity
  • any contraindication to MRI exam

结局指标

主要结局

Ratio between jugular vein flow and total arterial brain flow.

时间窗: day 0 = day of inclusion

Venous jugular flow is the sum right and left internal jugular vein flows. Total arterial flow is the sum of right and left internal carotid and vertebral arteries flows.

次要结局

  • CSF (cerebrospinal fluid) Stroke volumes(day 0 = day of inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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