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Clinical Trials/NCT04179383
NCT04179383
Recruiting
Not Applicable

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

University Hospital, Montpellier1 site in 1 country225 target enrollmentDecember 5, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Reversible Cerebral Vasoconstriction Syndrome
Sponsor
University Hospital, Montpellier
Enrollment
225
Locations
1
Primary Endpoint
Presence of, at least, one assumed trigger or risk factors
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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

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). 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.

Registry
clinicaltrials.gov
Start Date
December 5, 2019
End Date
September 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Time Frame: 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.

Secondary Outcomes

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

Study Sites (1)

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