Reversible Cerebrovascular Vasoconstriction SyndromeSVC-2RNCT03204110
Retinal Patterns in Reversible Cerebral Vasoconstriction Syndrome
An observational study of Reversible Cerebrovascular Vasoconstriction Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Reversible cerebral vasoconstriction syndrome (RCVS) is a clinico radiological entity characterized by severe headaches (associated or not with neurological complications) during one to 3 weeks, associated with a characteristic 'string and beads' appearance on cerebral arteries, which resolves spontaneously in 3… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Reversible Cerebrovascular Vasoconstriction Syndrome
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 6 Mar 2012to 23 Aug 2016
- 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
- No healthy volunteers
- Adult, Older adult
Study population: male and female with Reversible cerebral vasoconstriction syndrome
Who may be able to join
- repetitive thunderclap headache highly suggestive of RCVS (clinical syndrome)
- maximum delay of ten days between the first thunderclap headache (qualifying event) and patient's inclusion.
- informed written consent
Who cannot join
- intracranial aneurism on angiography (Brain MRI or angioscan)
- severe atheroma with cervical stenosis up to 80%
- medical history of diabetes and/or hypertension
- minor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non Invasive Assessment of Morphological and Functional Retinal Patterns in Reversible Cerebral Vasoconstriction Syndrome Using Transorbital Echotomography Doppler, Retinography and Retinal Vessel Analyser
Reversible cerebral vasoconstriction syndrome (RCVS) is a clinico radiological entity characterized by severe headaches (associated or not with neurological complications) during one to 3 weeks, associated with a characteristic 'string and beads' appearance on cerebral arteries, which resolves spontaneously in 3 months. The pathway is unknown. At early stage of the disease (at the first medical consultation) cerebral arterial abnormalities which are necessary for diagnosis are identified in only 20% of patients (brain magnetic resonance imagery (MRI) ,CT scan angiography), appearing with a delay on 2th or 3rd week after the first severe headache..
Retinal artery network is considered to be a window on brain microvasculature by sharing the same embryologic origin and physiopathology. A retinal arteriolar examination at early stage of RCVS could provide non invasively early clue to confirm diagnosis by identifying anatomical change and /or functional abnormalities at the microvascular level, whereas large cerebral artery abnormalities are still normal.
Read the detailed description
Reversible cerebral vasoconstriction syndrome (RCVS) is a clinico radiological entity characterized by severe headaches (associated or not with neurological complications) during one to 3 weeks, associated with a characteristic 'string and beads' appearance on cerebral arteries, which resolves spontaneously in 3 months.
The pathway is unknown. One strong hypothesis is that RCVS is a vasospasm and-vasodilatation disorder starting from small distal cerebral arteries progressing toward to medium sized and large sized cerebral arteries, and disappearing in 3 months.
At early stage of the disease (generally at the first medical consultation round 7 days after the first headache), arterial caliber anomalies cannot be identified on usual investigation (brain MRI, angioscan) in most of the case (80%). They are appearing secondary on repeated angiogram around the 2nd week or 3rd week, permitting to confirm the diagnosis, but with delay. Currently, small cerebral vessel arteries can't be studied directly . Retinal artery network is easy to study. It is considered to be a window on brain microvasculature by sharing the same embryologic origin and physiopathology. The investigators thus hypothesized that retinal arteriolar examination a early stage of RCVS could provide non invasively early clue to confirm diagnosis by identifying anatomical change and /or functional abnormalities at the microvascular level, whereas large cerebral artery abnormalities are still normal.
Hypothesis Arteriolar caliber and vasoreactivity abnormalities at the retinal microvascular level could be an early, non invasive and sensitive diagnostic marker of the RCVS at the first medical consultation in emergency.
- Keywords
- Reversible cerebral vasoconstriction syndrome, Anatomic and morphological retinal network analysis, Retinal vessel analyser, retinography, Prospective analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of retinal morphological microvascular abnormalities
The frequency of retinal abnormalities will be described at early stage of RCVS (< 10 days following the first thunderclap headache = qualifying event) • by measuring the retinal arteriolar caliber at baseline (micrometer, µm)
Measured: < 10 days
The frequency of retinal functional vascular abnormalities
The frequency and type of retinal abnormalities will be described at early stage of RCVS (< 10 days following the first thunderclap headache = qualifying event) • by measuring the meanflow value in central retinal artery (cm/s), ciliar arteries (cm/s) and ophthalmic arteries(cm/s) at baseline
- by measuring the diameter variation of retinal microvascular network (% of variation) during a vasoreactivity test (flicker stimulation with RVA)
Measured: < 10 days
The type of retinal morphological microvascular abnormalities
The type of retinal abnormalities will be described at early stage of RCVS (< 10 days following the first thunderclap headache = qualifying event) • by measuring the retinal arteriolar caliber at baseline (micrometer, µm)
Measured: < 10 days
The type of retinal functional vascular abnormalities
The type of retinal abnormalities will be described at early stage of RCVS (< 10 days following the first thunderclap headache = qualifying event) • by measuring the meanflow value in central retinal artery (cm/s), ciliar arteries (cm/s) and ophthalmic arteries(cm/s) at baseline
- by measuring the diameter variation of retinal microvascular network (% of variation) during a vasoreactivity test (flicker stimulation with RVA)
Measured: < 10 days
Secondary outcomes (3)
The kinetic of morphological retinal abnormalities during RCVS
The kinetic of morphological retinal abnormalities during RCVS course from the first neurological evaluation to final neurological follow up at 3 months (Day10, Day14, Day21 and Day 90) using the same morphological and functional measurements at the retinal level (RVA, retinography, and transorbital echo Doppler)
Measured: at Day10, Day14, Day21 and Day 90
the kinetic of morphological patterns on Brain RMI during RCVS course during RCVS course
The kinetic of morphological patterns at the cerebral level: Brain RMI (Magnetic resonance Imaging) at Day10 Day14 Day21 and Day 90 : existence or not and number of vasopasm , existence or not of ischemic lesions, existence or not of hemorrhagic lesions.
Measured: at Day10, Day 14, Day 21 and Day 90
the kinetic of functional patterns on cervico transcranial duplex evaluation during RCVS course
The kinetics of functional patterns at the cerebral level (men velocities cm/s for MCA CAA, BA, maximum systolic peak values on MCA, CAA and BA )using cervico transcranial duplex
Measured: at Day10, Day 14, Day 21 and Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start6 Mar 2012
- Primary completion11 Jul 2016
- Study completion23 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reversible Cerebrovascular Vasoconstriction SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- GOBRON Claire, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03204110
- Sponsor's protocol ID
- P100509
- Acronym
- SVC-2R
- Status last verified
- Jun 2017
- First submitted
- 9 Sep 2014
- Last updated
- 29 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Invasive Assessment of Morphological and Functional Retinal Patterns in Reversible Cerebral Vasoconstriction Syndrome Using Transorbital Echotomography Doppler, Retinography and Retinal Vessel Analyser
- ClinicalTrials.gov ID
- NCT03204110
- Acronym / sponsor ID
- SVC-2R / P100509
- Keywords
- Reversible cerebral vasoconstriction syndrome, Anatomic and morphological retinal network analysis, Retinal vessel analyser, retinography, Prospective analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 6 Mar 2012 (actual)
- Primary completion
- 11 Jul 2016 (actual)
- Study completion
- 23 Aug 2016 (actual)
- First posted
- 29 Jun 2017 (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 clinico radiological entity characterized by severe headaches (associated or not with neurological complications) during one to 3 weeks, associated with a characteristic 'string and beads' appearance on cerebral arteries, which resolves spontaneously in 3 months. The pathway is unknown. At early stage of the disease (at the first medical consultation) cerebral arterial abnormalities which are necessary for diagnosis are identified in only 20% of patients (brain magnetic resonance imagery (MRI) ,CT scan angiography), appearing with a delay on 2th or 3rd week after the first severe headache..
Retinal artery network is considered to be a window on brain microvasculature by sharing the same embryologic origin and physiopathology. A retinal arteriolar examination at early stage of RCVS could provide non invasively early clue to confirm diagnosis by identifying anatomical change and /or functional abnormalities at the microvascular level, whereas large cerebral artery abnormalities are still normal.
Detailed description
Reversible cerebral vasoconstriction syndrome (RCVS) is a clinico radiological entity characterized by severe headaches (associated or not with neurological complications) during one to 3 weeks, associated with a characteristic 'string and beads' appearance on cerebral arteries, which resolves spontaneously in 3 months.
The pathway is unknown. One strong hypothesis is that RCVS is a vasospasm and-vasodilatation disorder starting from small distal cerebral arteries progressing toward to medium sized and large sized cerebral arteries, and disappearing in 3 months.
At early stage of the disease (generally at the first medical consultation round 7 days after the first headache), arterial caliber anomalies cannot be identified on usual investigation (brain MRI, angioscan) in most of the case (80%). They are appearing secondary on repeated angiogram around the 2nd week or 3rd week, permitting to confirm the diagnosis, but with delay. Currently, small cerebral vessel arteries can't be studied directly . Retinal artery network is easy to study. It is considered to be a window on brain microvasculature by sharing the same embryologic origin and physiopathology. The investigators thus hypothesized that retinal arteriolar examination a early stage of RCVS could provide non invasively early clue to confirm diagnosis by identifying anatomical change and /or functional abnormalities at the microvascular level, whereas large cerebral artery abnormalities are still normal.
Hypothesis Arteriolar caliber and vasoreactivity abnormalities at the retinal microvascular level could be an early, non invasive and sensitive diagnostic marker of the RCVS at the first medical consultation in emergency.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- male and female with Reversible cerebral vasoconstriction syndrome
Key inclusion criteria (3 listed)
- repetitive thunderclap headache highly suggestive of RCVS (clinical syndrome)
- maximum delay of ten days between the first thunderclap headache (qualifying event) and patient's inclusion.
- informed written consent
Key exclusion criteria (4 listed)
- intracranial aneurism on angiography (Brain MRI or angioscan)
- severe atheroma with cervical stenosis up to 80%
- medical history of diabetes and/or hypertension
- minor
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
The frequency of retinal morphological microvascular abnormalities
Time frame: < 10 days
The frequency of retinal abnormalities will be described at early stage of RCVS (< 10 days following the first thunderclap headache = qualifying event) • by measuring the retinal arteriolar caliber at baseline (micrometer, µm)
The frequency of retinal functional vascular abnormalities
Time frame: < 10 days
The frequency and type of retinal abnormalities will be described at early stage of RCVS (< 10 days following the first thunderclap headache = qualifying event) • by measuring the meanflow value in central retinal artery (cm/s), ciliar arteries (cm/s) and ophthalmic arteries(cm/s) at baseline • by measuring the diameter variation of retinal microvascular network (% of variation) during a vasoreactivity test (flicker stimulation with RVA)
The type of retinal morphological microvascular abnormalities
Time frame: < 10 days
The type of retinal abnormalities will be described at early stage of RCVS (< 10 days following the first thunderclap headache = qualifying event) • by measuring the retinal arteriolar caliber at baseline (micrometer, µm)
The type of retinal functional vascular abnormalities
Time frame: < 10 days
The type of retinal abnormalities will be described at early stage of RCVS (< 10 days following the first thunderclap headache = qualifying event) • by measuring the meanflow value in central retinal artery (cm/s), ciliar arteries (cm/s) and ophthalmic arteries(cm/s) at baseline • by measuring the diameter variation of retinal microvascular network (% of variation) during a vasoreactivity test (flicker stimulation with RVA)
3 secondary outcomes
The kinetic of morphological retinal abnormalities during RCVS
Time frame: at Day10, Day14, Day21 and Day 90
the kinetic of morphological patterns on Brain RMI during RCVS course during RCVS course
Time frame: at Day10, Day 14, Day 21 and Day 90
the kinetic of functional patterns on cervico transcranial duplex evaluation during RCVS course
Time frame: at Day10, Day 14, Day 21 and Day 90
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 29 Jun 2017.
Related trials for Reversible Cerebrovascular 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.
GOBRON Claire, MD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Cerebrovascular Vasoconstriction Syndrome, run by Assistance Publique - Hôpitaux de Paris 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 3 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: finished, as of the sponsor's last update on 29 Jun 2017. 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?
The frequency of retinal morphological microvascular abnormalities (time frame: < 10 days). The study lists 4 primary outcomes in all. 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 Jun 2017.