Identification of Reversible Cerebral Vasoconstriction Syndrome's Precipitating Factors. Triggers And Risk Factors to Develop a Reversible Cerebral Vasoconstriction Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 225
- 试验地点
- 1
- 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:
- Determine if migraine, anxiety, depression are risk factors of RCVS.
- Determine the role of precipitating factors and risk factors on the RCVS's prognosis in short, medium and long term.
- 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
- 是
入选标准
- •For the Patients
- •Men and women of 18 and more years old
- •Taken care in the CHU of Montpellier
- •Diagnosis of SVCR or SVCR without visible vasoconstriction makes in 14 days preceding the inclusion
- •According to the consensual criteria of diagnosis and those of the international classification of the headaches ICHD-3
- •Informed consent and writes for the participation in the study
- •For volunteers
- •Men and women of 18 and more, mated in the Cases on the sex and the age
- •Patients with an acute pathology not Neurological and not vascular (for example, eye foreign body) OR Healthy Subjects
- •Informed written consent and for the participation in the study
排除标准
- •Coma, insanity, language barrier or severe aphasia preventing from answering the questions
- •Follow-up considered impossible for 3 months (e.g.: priority associated pathology in the care, the transfer(transformation))
- •People placed under legal protection
- •Refusal to participate in the study
研究组 & 干预措施
Patient
Patient presenting a Reversible Cerebral Vasoconstriction Syndrome (RCVS) :
- Questionnaires about anxiety, depression ;
- Constitution of a biobank (if specific consent) at inclusion and at 3 months
干预措施: Constitution of a biobank (Other)
Volunteers
Volunteers admitted for a non neurological or non vascular pathology or healthy volunteers accompanying a patient :
- Questionnaires about anxiety, depression ;
- Constitution of a blood biobank (if specific consent)
干预措施: Constitution of a biobank (Other)
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)