Triggers And Risk Factors to Develop a Reversible Cerebral Vasoconstriction Syndrome

Not Applicable

Recruiting

• Conditions: Reversible Cerebral Vasoconstriction Syndrome
• Interventions: Other: Constitution of a biobank

• Registration Number: NCT04179383
• Lead Sponsor: University Hospital, Montpellier

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.

Study Timeline

• Study First Submitted: 2018-11-29
• Study First Submitted QC: 2019-11-25
• Study First Posted: 2019-11-27
• Study Start: 2019-12-05
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-27
• Last Update Posted: 2024-05-29
• Primary Completion: 2024-06
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Volunteers	Constitution of a biobank	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)
Patient	Constitution of a biobank	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

Primary Outcome Measures

Name	Time	Method
Presence of, at least, one assumed trigger or risk factors	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 Outcome Measures

Name	Time	Method
Comparison between precipitating factors and clinico-radiological manifestations of RCVS	3 months	Evaluation of Modified Rankin Score, evaluated 3 month after clinical beginning, according to the presence of precipitating factors.

Trial Locations

Locations (1)

Gui de Chauliac Hospital; 🇫🇷 Montpellier, France