Triggers And Risk Factors to Develop a Reversible Cerebral Vasoconstriction Syndrome (TARDIS)

University Hospital Center (CHU)

Status: Enrolling

Conditions: Reversible Cerebral Vasoconstriction Syndrome

Treatments: Other: Constitution of a biobank

Study type: Interventional

Funder types: Other

Identifiers

NCT04179383

9894

Details and patient eligibility

About

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.

Full 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.

Enrollment: 225 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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225 participants in 2 patient groups

Patient

Other group

Description:

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

Treatment:

Other: Constitution of a biobank

Volunteers

Other group

Description:

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)

Treatment:

Other: Constitution of a biobank