Reversible Cerebrovascular Vasoconstriction Syndrome Clinical Trial
— SVC-2ROfficial title:
Non Invasive Assessment of Morphological and Functional Retinal Patterns in Reversible Cerebral Vasoconstriction Syndrome Using Transorbital Echotomography Doppler, Retinography and Retinal Vessel Analyser
| Verified date | June 2017 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 23 |
| Est. completion date | August 23, 2016 |
| Est. primary completion date | July 11, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - intracranial aneurism on angiography (Brain MRI or angioscan) - severe atheroma with cervical stenosis up to 80% - medical history of diabetes and/or hypertension - minor |
| Country | Name | City | State |
|---|---|---|---|
| France | Physiological department, Lariboisière hospital | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | < 10 days | |
| Primary | 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) |
< 10 days | |
| Primary | 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) | < 10 days | |
| Primary | 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) |
< 10 days | |
| Secondary | 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) | at Day10, Day14, Day21 and Day 90 | |
| Secondary | 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. | at Day10, Day 14, Day 21 and Day 90 | |
| Secondary | 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 | at Day10, Day 14, Day 21 and Day 90 |