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

Primary Purpose

Reversible Cerebral Vasoconstriction Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Constitution of a biobank
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Reversible Cerebral Vasoconstriction Syndrome focused on measuring Thunderclap headache

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts 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 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

Sites / Locations

  • Gui de Chauliac HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Patient

Volunteers

Arm 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

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
Comparison between precipitating factors and clinico-radiological manifestations of RCVS
Evaluation of Severity of cerebral arteries' vasoconstriction, according to the presence of precipitating factor
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
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.

Full Information

First Posted
November 29, 2018
Last Updated
January 31, 2023
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT04179383
Brief Title
Triggers And Risk Factors to Develop a Reversible Cerebral Vasoconstriction Syndrome
Acronym
TARDIS
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 5, 2019 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: Determine if migraine, anxiety, depression are risk factors of RCVS. Determine the role of precipitating factors and risk factors on the RCVS's prognosis in short, medium and long term. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reversible Cerebral Vasoconstriction Syndrome
Keywords
Thunderclap headache

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
225 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient
Arm Type
Other
Arm 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
Arm Title
Volunteers
Arm Type
Other
Arm 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)
Intervention Type
Other
Intervention Name(s)
Constitution of a biobank
Intervention Description
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'.
Primary Outcome Measure Information:
Title
Presence of, at least, one assumed trigger or risk factors
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Comparison between precipitating factors and clinico-radiological manifestations of RCVS
Description
Evaluation of Clinical manifestations (headache, seizures, focal neurological deficit) according to the presence of precipitating factors
Time Frame
3 months
Title
Comparison between precipitating factors and clinico-radiological manifestations of RCVS
Description
Evaluation of Brain lesion (stroke, posterior reversible encephalopathy syndrome) according to the presence of precipitating factors
Time Frame
3 months
Title
Comparison between precipitating factors and clinico-radiological manifestations of RCVS
Description
Evaluation of Severity of cerebral arteries' vasoconstriction, according to the presence of precipitating factor
Time Frame
3 months
Title
Comparison between precipitating factors and clinico-radiological manifestations of RCVS
Description
Evaluation of Lesion of intracranial and / or cervical arteries, according to the presence of precipitating factors
Time Frame
3 months
Title
Comparison between precipitating factors and clinico-radiological manifestations of RCVS
Description
Evaluation of Modified Rankin Score, evaluated 3 month after clinical beginning, according to the presence of precipitating factors.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lucas CORTI
Phone
06.76.31.63.12
Email
l-corti@chu-montpellier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Anne DUCROS, PU-PH
Email
a-ducros@chu-montpellier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucas CORTI
Organizational Affiliation
CHU de Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gui de Chauliac Hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucas CORTI
Phone
06.76.31.63.12
Email
l-corti@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Anne DUCROS
Email
a-ducros@chu-montpellier.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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Triggers And Risk Factors to Develop a Reversible Cerebral Vasoconstriction Syndrome

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