NCT04179383

Triggers And Risk Factors to Develop a Reversible Cerebral Vasoconstriction Syndrome

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 225 (estimated)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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.

Conditions

• Reversible Cerebral Vasoconstriction Syndrome

Interventions

Type	Name	Description
OTHER	Constitution of a biobank	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'.

Timeline

• Start date: 2019-12-05
• Primary completion: 2024-06-01
• Completion: 2024-09-01
• First posted: 2019-11-27
• Last updated: 2024-05-29

Locations

1 site across 1 country: France