Reversible Cerebral Vasoconstriction SyndromeTARDISNCT04179383
Triggers And Risk Factors to Develop a Reversible Cerebral Vasoconstriction Syndrome
A study testing Constitution of a biobank in people with Reversible Cerebral Vasoconstriction Syndrome, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Reversible Cerebral Vasoconstriction Syndrome
- What is being tested?
- Constitution of a biobank
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteFrance
- Study dates
- 5 Dec 2019to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Anne DUCROS, PU-PH contact
France1 site, 1 recruiting
- Recruiting
Gui de Chauliac Hospital
Montpellier, 34295
Lucas CORTI, 06.76.31.63.12, l-corti@chu-montpellier.fr
Anne DUCROS, a-ducros@chu-montpellier.fr
About this study
Official title: 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.
Read the 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.
- Being tested
- Constitution of a biobank
- Keywords
- Thunderclap headache
- Medical subject headings
- Headache Disorders, Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constitution of a biobankOther
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'.
| Study group | Role | What they receive |
|---|---|---|
| Patient | Other | 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 Receives: Other: Constitution of a biobank |
| Volunteers | Other | 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) Receives: Other: Constitution of a biobank |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start5 Dec 2019
- Primary completionJun 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reversible Cerebral Vasoconstriction SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucas CORTI, Principal investigator, CHU de Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04179383
- Sponsor's protocol ID
- 9894
- Acronym
- TARDIS
- Status last verified
- May 2024
- First submitted
- 29 Nov 2018
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Reversible Cerebral Vasoconstriction Syndrome's Precipitating Factors. Triggers And Risk Factors to Develop a Reversible Cerebral Vasoconstriction Syndrome
- ClinicalTrials.gov ID
- NCT04179383
- Acronym / sponsor ID
- TARDIS / 9894
- Keywords
- Thunderclap headache
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 5 Dec 2019 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 27 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | Other | Other: Constitution of a biobankPatient 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 | Other | Other: Constitution of a biobankVolunteers 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) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- For the Patients
- For volunteers
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Constitution of a biobankWe 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 | Patient, Volunteers |
Primary outcome
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.
5 secondary outcomes
Comparison between precipitating factors and clinico-radiological manifestations of RCVS
Time frame: 3 months
Comparison between precipitating factors and clinico-radiological manifestations of RCVS
Time frame: 3 months
Comparison between precipitating factors and clinico-radiological manifestations of RCVS
Time frame: 3 months
Comparison between precipitating factors and clinico-radiological manifestations of RCVS
Time frame: 3 months
Comparison between precipitating factors and clinico-radiological manifestations of RCVS
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Individual participant dataSharing planned: No
Related trials for Reversible Cerebral Vasoconstriction Syndrome
Active, not recruitingObservational study
Florida Cerebrovascular Disease Biorepository and Genomics Center
Cerebrovascular Disease, Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne DUCROS, PU-PH contact
Lucas CORTI principal investigator
CHU de Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Constitution of a biobank in people with Reversible Cerebral Vasoconstriction Syndrome, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucas CORTI (06.76.31.63.12, l-corti@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of, at least, one assumed trigger or risk factors (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.