Triggers And Risk Factors to Develop a Reversible Cerebral Vasoconstriction Syndrome

NCT ID: NCT04179383

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 225 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-05
• Study Completion Date: 2024-09-30

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.

Conditions

Reversible Cerebral Vasoconstriction Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Patient

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

Group Type: OTHER

Constitution of a biobank

Intervention Type: 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'.

Volunteers

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)

Group Type: OTHER

Constitution of a biobank

Intervention Type: 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'.

Interventions

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'.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lucas CORTI

Role: PRINCIPAL_INVESTIGATOR

CHU de Montpellier

Locations

Gui de Chauliac Hospital

Montpellier, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Lucas CORTI

Role: CONTACT

l-corti@chu-montpellier.fr

06.76.31.63.12

Anne DUCROS, PU-PH

Role: CONTACT

a-ducros@chu-montpellier.fr

Facility Contacts

Lucas CORTI

Role: primary

l-corti@chu-montpellier.fr

06.76.31.63.12

Anne DUCROS

Role: backup

a-ducros@chu-montpellier.fr

Other Identifiers

9894

Identifier Type: -

Identifier Source: org_study_id