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

May 27, 2024 updated by: University Hospital, Montpellier

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
225

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Presence of, at least, one assumed trigger or risk factors
Time Frame: 3 months

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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Comparison between precipitating factors and clinico-radiological manifestations of RCVS
Time Frame: 3 months
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
Time Frame: 3 months
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
Time Frame: 3 months
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
Time Frame: 3 months
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
Time Frame: 3 months
Evaluation of Modified Rankin Score, evaluated 3 month after clinical beginning, according to the presence of precipitating factors.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Montpellier

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lucas CORTI, CHU de Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 5, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 27, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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