An observational study in Reversible Cerebral Vasoconstriction Syndrome, sponsored by Nantes University Hospital. Completed at 1 site in France. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-24.
Sponsored by Nantes University Hospital · Observational
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.
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 :
For control :
9,217 studies on the registry are indexed under Syndrome; 1,031 are open to participants now.
This study's enrollment of 62 is below the median of 102 across 2,209 observational studies indexed under Syndrome.
Browse Syndrome studies →Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients and Healthy subjects
Inclusion Criteria for patients :
Inclusion criteria for control :
Exclusion Criteria:
Non inclusion criteria for patient :
Exclusion criteria for patient :
Non inclusion criteria for control :
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 without SVCR (current and history)
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)
Time frame: 24 hours
BHI (Breath Holding Index)
BHI measure on middle cerebral arteries by transcranial ultrasound
Time frame: at day 0, month 1, month 3
Pulse wave velocity (PWV)
Pulse wave velocity mesaure from carotid to femoral artery
Time frame: at day 0, month 1, month 3
Relationship between cerebral and systemic endothelial function
Comparison of BHI and VOP evolution
Time frame: at day 0, month 1, month 3
Renal failure
Diminution of creatinin clearance\<100 ml/min/1.73m2
Time frame: Day 0
Occurence of stroke or cerebral oedema
Occurrence of ischemic stroke, cerebral haemorrhage, cerebral oedema
Time frame: 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
Time frame: 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
Time frame: at day 0, month 1, month 3
Comparison between PWV (cm/s)
Comparison between PWV (cm/s) between patients and control group
Time frame: at 3 months
Comparison between BHI (cm/s)
Comparison between BHI (cm/s) between patients and control group
Time frame: at 3 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Nantes University Hospital