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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Reversible Cerebral Vasoconstriction Syndrome
• Intervention / Treatment: Other: Constitution of a biobank

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.

• Study Type: Interventional
• Enrollment (Anticipated): 225
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lucas CORTI; Phone Number: 06.76.31.63.12; Email: l-corti@chu-montpellier.fr
• Study Contact Backup: Name: Anne DUCROS, PU-PH; Email: a-ducros@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • Gui de Chauliac Hospital
    • Contact: Lucas CORTI; Phone Number: 06.76.31.63.12; Email: l-corti@chu-montpellier.fr
    • Contact: Anne Ducros; Email: a-ducros@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 admitted in the pole Neurosciences Head and Neck (NSTC) of the CHU for an acute pathology not Neurological and not vascular (for example, eye foreign body) OR Healthy Subjects accompanying or visiting a patient admitted person in the CHU
  • 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	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'.
Other: 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)	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'.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison between precipitating factors and clinico-radiological manifestations of RCVS	Evaluation of Clinical manifestations (headache, seizures, focal neurological deficit) according to the presence of precipitating factors	3 months
Comparison between precipitating factors and clinico-radiological manifestations of RCVS	Evaluation of Brain lesion (stroke, posterior reversible encephalopathy syndrome) according to the presence of precipitating factors	3 months
Comparison between precipitating factors and clinico-radiological manifestations of RCVS	Evaluation of Severity of cerebral arteries' vasoconstriction, according to the presence of precipitating factor	3 months
Comparison between precipitating factors and clinico-radiological manifestations of RCVS	Evaluation of Lesion of intracranial and / or cervical arteries, according to the presence of precipitating factors	3 months
Comparison between precipitating factors and clinico-radiological manifestations of RCVS	Evaluation of Modified Rankin Score, evaluated 3 month after clinical beginning, according to the presence of precipitating factors.	3 months

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Lucas CORTI, CHU de Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2019
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: November 29, 2018
• First Submitted That Met QC Criteria: November 25, 2019
• First Posted (Actual): November 27, 2019

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 24, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Thunderclap headache
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: 9894

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No