跳至主要内容
临床试验/NCT04179383
NCT04179383招募中不适用

Identification of Reversible Cerebral Vasoconstriction Syndrome's Precipitating Factors. Triggers And Risk Factors to Develop a Reversible Cerebral Vasoconstriction Syndrome

University Hospital, Montpellier2 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2019年12月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
225
试验地点
2
主要终点
Presence of, at least, one assumed trigger or risk factors

研究概览

简要总结

This study will be the first to evaluate the role played by potential precipitating factors and risk factors in Reversible Cerebral Vasoconstriction Syndrome (RCVS) through of prospective selection of carefully characterised patients and controls. The impact of these factors on the prognosis will be evaluated through a follow-up assessment of patients.

Our study will include the formation of a clinicoradiological database and a biobank (plasma, cerebro-spinal fluid, DNA) which will be the tools of a future large multicentre study on RCVS.

详细描述

Introduction : Reversible Cerebral Vasoconstriction Syndrome (RCVS) combines headaches and segmental constriction of cerebral arteries that resolves within 3 months.

It is the most recurrent reason of cerebral arteriopathy in people under 70 and of thunderclap headache in absence of aneurysmal subarachnoid haemorrhage.

Objectives :

  • Principal: identify RCVS's precipitating factors
  • Secondary:
  1. Determine if migraine, anxiety, depression are risk factors of RCVS.
  2. Determine the role of precipitating factors and risk factors on the RCVS's prognosis in short, medium and long term.
  3. Start a formation of a large clinicoradiological database and a biobank (plasma, cerebro-spinal fluid, DNA).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Presence of, at least, one assumed trigger or risk factors

时间窗: 3 months

The relationship between the assumed precipitating factors and RCVS will be evaluated by comparing the frequencies of exposure of suspected precipitating factors between cases and controls, and given by calculating an odds ratio. The assumed trigger or risk factors are : a physical and / or emotional stress within 30 days before the clinical beginning; presence of chronic neurological or psychiatric disease (migraine, primary thunderclap headache or circumstancial headache, anxiety or depression); vascular risk factors; and hormonal status in women.

次要结局

  • Comparison between precipitating factors and clinico-radiological manifestations of RCVS(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Triggers And Risk Factors to Develop a Reversible... | 临床试验