Triggers And Risk Factors to Develop a Reversible Cerebral Vasoconstriction Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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). Methodology : Monocentric analytic observational 'Case - Control' study with prospective inclusion of cases in a follow-up cohort. This type of study is nevertheless considered interventional because we are collecting additional blood and CSF samples to constitute a biobank.

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

Conditions
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Reversible Cerebral Vasoconstriction Syndrome

Intervention / Treatment
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* Other: Constitution of a biobank


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 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 Exclusion criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patient<br>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 | Other: Constitution of a biobank<br>* We are collecting additional blood and CSF samples for patients (during RCVS episode and after resolution of RCVS episode) and for control subjects to constitute a biobank, in order to compare different biologic parameters between RCVS patients and healthy volunteers. A specific agreement will be asked to patients and control subjects before collection of samples. This is why this study is classified as 'interventional' rather than 'observational'.<br>|
| Other: Volunteers<br>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) | Other: Constitution of a biobank<br>* We are collecting additional blood and CSF samples for patients (during RCVS episode and after resolution of RCVS episode) and for control subjects to constitute a biobank, in order to compare different biologic parameters between RCVS patients and healthy volunteers. A specific agreement will be asked to patients and control subjects before collection of samples. This is why this study is classified as 'interventional' rather than 'observational'.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of, at least, one assumed trigger or risk factors | 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between precipitating factors and clinico-radiological manifestations of RCVS | Evaluation of Clinical manifestations (headache, seizures, focal neurological deficit) according to the presence of precipitating factors | 3 months | 
| Comparison between precipitating factors and clinico-radiological manifestations of RCVS | Evaluation of Brain lesion (stroke, posterior reversible encephalopathy syndrome) according to the presence of precipitating factors | 3 months | 
| Comparison between precipitating factors and clinico-radiological manifestations of RCVS | Evaluation of Severity of cerebral arteries' vasoconstriction, according to the presence of precipitating factor | 3 months | 
| Comparison between precipitating factors and clinico-radiological manifestations of RCVS | Evaluation of Lesion of intracranial and / or cervical arteries, according to the presence of precipitating factors | 3 months | 
| Comparison between precipitating factors and clinico-radiological manifestations of RCVS | Evaluation of Modified Rankin Score, evaluated 3 month after clinical beginning, according to the presence of precipitating factors. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thunderclap headache