Triggers And Risk Factors to Develop a Reversible Cerebral Vasoconstriction Syndrome

NCT04179383 | Recruiting

• 1 other identifier: 9894
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

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.

Conditions

Reversible Cerebral Vasoconstriction Syndrome

Keywords

Thunderclap headache

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Comparison between precipitating factors and clinico-radiological manifestations of RCVS

  3 months

• Comparison between precipitating factors and clinico-radiological manifestations of RCVS

  3 months

• Comparison between precipitating factors and clinico-radiological manifestations of RCVS

  3 months

• Comparison between precipitating factors and clinico-radiological manifestations of RCVS

  3 months

• Comparison between precipitating factors and clinico-radiological manifestations of RCVS

  3 months

Study Arms (2)

Patient

OTHER

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

Volunteers

OTHER

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

Interventions

Constitution of a biobank OTHER

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'.

Patient; Volunteers

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For the Patients
• Men and women of 18 and more years old
• Taken care in the CHU of Montpellier
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Gui de Chauliac Hospital

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Headache Disorders, Primary

Condition Hierarchy (Ancestors)

Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Lucas CORTI

  CHU de Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucas CORTI

CONTACT

06.76.31.63.12; l-corti@chu-montpellier.fr

Anne DUCROS, PU-PH

CONTACT

a-ducros@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: November 27, 2019
• Study Start: December 5, 2019
• Primary Completion: June 1, 2024
• Study Completion: September 1, 2024
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)