Reversible Cerebral Vasoconstriction SyndromeDESSNCT04463212
Endothelial Dysfunction in Reversible Cerebral Vasoconstriction Syndrome
An observational study of Reversible Cerebral Vasoconstriction Syndrome, run by Nantes University Hospital at 1 site in France.
Trial summary
Reversible Cerebral Vasoconstriction Syndrome (RCVS) is a syndrome described at the end of the 20th century. Generally, it has a benign course. It is revealed by acute headaches, in different circumstances such as sexual activity, physical exertion or emotional disturbances. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Reversible Cerebral Vasoconstriction Syndrome
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jan 2021to 12 Jan 2024
- Phase
- Observational
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients and Healthy subjects
Who may be able to join
- Aged from 18 to 80 years old
- RVCS diagnosis evoked on clinic and radiologic finding
- Last headache was 15 days ago
- Oral consent
- Register in French social security
- Aged from 18 to 80 years old
Show all 11Show fewer
- Hypothesis of RCVS in clinical presentation and on cerebral imaging
- Last headache less than 3 days old
- Oral consent
- Register in French social security
- Person under guardianship, curatorship or safeguarding of justice
Who cannot join
- Non inclusion criteria for patient :
- Pregnant women
- Tobacco, coffee, alcohol, drugs or vasoactive recreational substances use within 2 hours prior to the examination.
- Person under guardianship, curatorship or safeguarding of justice
- Non sinusal rhythm on EKG
- Impossible of Breath holding for 30 secondes
Show all 12Show fewer
- No reversibility at 3 months
- Non inclusion criteria for control :
- Pregnant women
- Tobacco, coffee, alcohol, drugs or vasoactive recreational substances use within 2 hours prior to the examination.
- Non sinusal rhythm on EKG
- Impossible of Breath holding for 30 secondes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Systemic Endothelial Dysfunction in Reversible Cerebral Vasoconstriction Syndrome : a Case Control Study
Reversible Cerebral Vasoconstriction Syndrome (RCVS) is a syndrome described at the end of the 20th century. Generally, it has a benign course. It is revealed by acute headaches, in different circumstances such as sexual activity, physical exertion or emotional disturbances. But, in few cases, it might be complicated by seizure, stroke and subarachnoid haemorrhage. The diagnosis is confirmed on radiological examination, which shows diffuse cerebral vasoconstriction of brain vessel. It calls reversible because at three month, vasoconstriction disappears. Most cases occur during post partum or after serotoninergic/adrenergic drug use. The pathophysiology is unknown but a transient disturbance in the control of cerebrovascular tone by sympathic hyperactivity and/or endothelial dysfunction are suspected. The assessment of endothelial dysfunction in brain is possible with transcranial doppler. Chen et al. showed an impairment of vasodilatation post apnea induced called BHI on RCVS subjects compared with healthy control. BHI is a reflect of endothelial function in brain. Currently, investigators do not know if endothelial dysfunction occurred only in brain or if it may occur in systemic vessel. Some case reports talk about systemic complication such as kidney infarct or hepatic arterial vasospasm so a systemic vascular dysfunction may be suspected. In this study, researchers will study systemic endothelial function by measure of the pulse wave velocity during RCVS and after its recovering at 3 months, and compare it at healthy controls.
Read the detailed description
The investigators lead a case control study to find a systemic endothelial dysfunction by the using of Complior device. Complior is a mechanographer who calculates pulse wave velocity (PWV). Pulse wave velocity is a reflect of arterial stiffness and it's correlate with endothelial dysfunction. For BHI, a Philips echograph is used before and after 30 second of breath holding.
Study protocol is :
For Patient :
- Day 0 : in hospital : anamnesis, medical history, physic examination, EKG, blood sample analysis, BHI, PWV analysis
- Month 1 : in medical visit : medical evolution, physic examination, EKG, blood sample analysis, BHI, PWV analysis
- Month 3 : in medical visit : medical evolution, physic examination, EKG, blood sample analysis, BHI, PWV analysis, cerebral angioCT Scan
For control :
- Day 0 : in hospital : medical history, physic examination, EKG, BHI, PWV analysis
- Keywords
- Endothelial dysfunction, Reversible cerebral vasoconstriction syndrome, Arterial stiffness, Breath holding index, Pulse wave velocity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient | Diagnosis of probable SVCR evoked, faced with a single or repeated episode of unusual thunderclap or rapidly progressive headache, and demonstration of diffuse vasospasms via sectional imaging (angiography, angio-MRI or cerebral arteriography) or an increase in transcranial doppler speeds | |
| Subject control | Subject without SVCR (current and history) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare systemic endothelial function between patient and healthy subject
By using Complior, researchers assess systemic endothelial function at inclusion on patient and healthy volunteer person by pulse wave velocity (cm.s-1)
Measured: 24 hours
Secondary outcomes (9)
BHI (Breath Holding Index)
BHI measure on middle cerebral arteries by transcranial ultrasound
Measured: at day 0, month 1, month 3
Pulse wave velocity (PWV)
Pulse wave velocity mesaure from carotid to femoral artery
Measured: at day 0, month 1, month 3
Relationship between cerebral and systemic endothelial function
Comparison of BHI and VOP evolution
Measured: at day 0, month 1, month 3
Renal failure
Diminution of creatinin clearance<100 ml/min/1.73m2
Measured: Day 0
Occurence of stroke or cerebral oedema
Occurrence of ischemic stroke, cerebral haemorrhage, cerebral oedema
Measured: at day 0, month 1, month 3
Comparison of PWV between patients with or without arterial hypertension
Comparison between middle PWV (cm/s) of patients with arterial hypertension and patients without arterial hypertension
Measured: at day 0, month 1, month 3
Comparison of BHI between patients with or without arterial hypertension
Comparison between middle BHI of patients with arterial hypertension and patients without arterial hypertension
Measured: at day 0, month 1, month 3
Comparison between PWV (cm/s)
Comparison between PWV (cm/s) between patients and control group
Measured: at 3 months
Comparison between BHI (cm/s)
Comparison between BHI (cm/s) between patients and control group
Measured: at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start29 Jan 2021
- Primary completion12 Jan 2024
- Study completion12 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04463212
- Sponsor's protocol ID
- RC20_0280
- Acronym
- DESS
- Status last verified
- Jan 2024
- First submitted
- 3 Jul 2020
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Constant Dit Beaufils P, Barbin L, Pere M, Colleu C, Connault J, Preterre C, Guillon B, de Gaalon S. Systemic Arterial Stiffness in Reversible Cerebral Vasoconstriction Syndrome: A Prospective Case-Control Study. Eur J Neurol. 2026 Feb;33(2):e70495. doi: 10.1111/ene.70495.
PubMed 41589411
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Endothelial Dysfunction in Reversible Cerebral Vasoconstriction Syndrome : a Case Control Study
- ClinicalTrials.gov ID
- NCT04463212
- Acronym / sponsor ID
- DESS / RC20_0280
- Keywords
- Endothelial dysfunction, Reversible cerebral vasoconstriction syndrome, Arterial stiffness, Breath holding index, Pulse wave velocity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 29 Jan 2021 (actual)
- Primary completion
- 12 Jan 2024 (actual)
- Study completion
- 12 Jan 2024 (actual)
- First posted
- 9 Jul 2020 (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.
Reversible Cerebral Vasoconstriction Syndrome (RCVS) is a syndrome described at the end of the 20th century. Generally, it has a benign course. It is revealed by acute headaches, in different circumstances such as sexual activity, physical exertion or emotional disturbances. But, in few cases, it might be complicated by seizure, stroke and subarachnoid haemorrhage. The diagnosis is confirmed on radiological examination, which shows diffuse cerebral vasoconstriction of brain vessel. It calls reversible because at three month, vasoconstriction disappears. Most cases occur during post partum or after serotoninergic/adrenergic drug use. The pathophysiology is unknown but a transient disturbance in the control of cerebrovascular tone by sympathic hyperactivity and/or endothelial dysfunction are suspected. The assessment of endothelial dysfunction in brain is possible with transcranial doppler. Chen et al. showed an impairment of vasodilatation post apnea induced called BHI on RCVS subjects compared with healthy control. BHI is a reflect of endothelial function in brain. Currently, investigators do not know if endothelial dysfunction occurred only in brain or if it may occur in systemic vessel. Some case reports talk about systemic complication such as kidney infarct or hepatic arterial vasospasm so a systemic vascular dysfunction may be suspected. In this study, researchers will study systemic endothelial function by measure of the pulse wave velocity during RCVS and after its recovering at 3 months, and compare it at healthy controls.
Detailed description
The investigators lead a case control study to find a systemic endothelial dysfunction by the using of Complior device. Complior is a mechanographer who calculates pulse wave velocity (PWV). Pulse wave velocity is a reflect of arterial stiffness and it's correlate with endothelial dysfunction. For BHI, a Philips echograph is used before and after 30 second of breath holding.
Study protocol is :
For Patient :
- Day 0 : in hospital : anamnesis, medical history, physic examination, EKG, blood sample analysis, BHI, PWV analysis
- Month 1 : in medical visit : medical evolution, physic examination, EKG, blood sample analysis, BHI, PWV analysis
- Month 3 : in medical visit : medical evolution, physic examination, EKG, blood sample analysis, BHI, PWV analysis, cerebral angioCT Scan
For control :
- Day 0 : in hospital : medical history, physic examination, EKG, BHI, PWV analysis
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | – | –Diagnosis of probable SVCR evoked, faced with a single or repeated episode of unusual thunderclap or rapidly progressive headache, and demonstration of diffuse vasospasms via sectional imaging (angiography, angio-MRI or cerebral arteriography) or an increase in transcranial doppler speeds |
| Subject control | – | –Subject without SVCR (current and history) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients and Healthy subjects
Key inclusion criteria (11 listed)
- Aged from 18 to 80 years old
- RVCS diagnosis evoked on clinic and radiologic finding
- Last headache was 15 days ago
- Oral consent
- Register in French social security
Key exclusion criteria (12 listed)
- Pregnant women
- Tobacco, coffee, alcohol, drugs or vasoactive recreational substances use within 2 hours prior to the examination.
- Person under guardianship, curatorship or safeguarding of justice
- Non sinusal rhythm on EKG
- Impossible of Breath holding for 30 secondes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Compare systemic endothelial function between patient and healthy subject
Time frame: 24 hours
By using Complior, researchers assess systemic endothelial function at inclusion on patient and healthy volunteer person by pulse wave velocity (cm.s-1)
9 secondary outcomes
BHI (Breath Holding Index)
Time frame: at day 0, month 1, month 3
Pulse wave velocity (PWV)
Time frame: at day 0, month 1, month 3
Relationship between cerebral and systemic endothelial function
Time frame: at day 0, month 1, month 3
Renal failure
Time frame: Day 0
Occurence of stroke or cerebral oedema
Time frame: at day 0, month 1, month 3
Comparison of PWV between patients with or without arterial hypertension
Time frame: at day 0, month 1, month 3
Comparison of BHI between patients with or without arterial hypertension
Time frame: at day 0, month 1, month 3
Comparison between PWV (cm/s)
Time frame: at 3 months
Comparison between BHI (cm/s)
Time frame: at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Derived from this study: PubMed 41589411Constant Dit Beaufils P, Barbin L, Pere M, Colleu C, Connault J, Preterre C, Guillon B, de Gaalon S. Systemic Arterial Stiffness in Reversible Cerebral Vasoconstriction Syndrome: A Prospective Case-Control Study. Eur J Neurol. 2026 Feb;33(2):e70495. doi: 10.1111/ene.70495.
- Individual participant dataSharing planned: No
Related trials for Reversible Cerebral Vasoconstriction Syndrome
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Reversible Cerebral Vasoconstriction Syndrome, run by Nantes University Hospital 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 11 inclusion and 12 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: finished, as of the sponsor's last update on 24 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare systemic endothelial function between patient and healthy subject (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04463212, which also lists 1 linked publication.
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 24 Jan 2024.