Clinical trial NCT04179383: Triggers And Risk Factors to Develop a Reversible Cerebral Vasoconstriction Syndrome
Official title: Identification of Reversible Cerebral Vasoconstriction Syndrome's Precipitating Factors. Triggers And Risk Factors to Develop a Reversible Cerebral Vasoconstriction Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Reversible Cerebral Vasoconstriction Syndrome
Keywords: Thunderclap headache
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-11-27
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Presence of, at least, one assumed trigger or risk factors
timeFrame: 3 months
Secondary outcomes:
measure: Comparison between precipitating factors and clinico-radiological manifestations of RCVS
timeFrame: 3 months
measure: Comparison between precipitating factors and clinico-radiological manifestations of RCVS
timeFrame: 3 months
measure: Comparison between precipitating factors and clinico-radiological manifestations of RCVS
timeFrame: 3 months
measure: Comparison between precipitating factors and clinico-radiological manifestations of RCVS
timeFrame: 3 months
measure: Comparison between precipitating factors and clinico-radiological manifestations of RCVS
timeFrame: 3 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Gui de Chauliac Hospital
Study officials:
affiliation: CHU de Montpellier
name: Lucas CORTI
role: PRINCIPAL_INVESTIGATOR
References: