Endothelial Dysfunction in Reversible Cerebral Vasoconstriction Syndrome
- Conditions
- Reversible Cerebral Vasoconstriction Syndrome
- Registration Number
- NCT04463212
- Lead Sponsor
- Nantes University Hospital
- Brief 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. 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
Not provided
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
Exclusion criteria for patient :
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Compare systemic endothelial function between patient and healthy subject 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)
- Secondary Outcome Measures
Name Time Method Pulse wave velocity (PWV) at day 0, month 1, month 3 Pulse wave velocity mesaure from carotid to femoral artery
Relationship between cerebral and systemic endothelial function at day 0, month 1, month 3 Comparison of BHI and VOP evolution
Comparison of PWV between patients with or without arterial hypertension at day 0, month 1, month 3 Comparison between middle PWV (cm/s) of patients with arterial hypertension and patients without arterial hypertension
Comparison of BHI between patients with or without arterial hypertension at day 0, month 1, month 3 Comparison between middle BHI of patients with arterial hypertension and patients without arterial hypertension
Comparison between BHI (cm/s) at 3 months Comparison between BHI (cm/s) between patients and control group
Renal failure Day 0 Diminution of creatinin clearance\<100 ml/min/1.73m2
Occurence of stroke or cerebral oedema at day 0, month 1, month 3 Occurrence of ischemic stroke, cerebral haemorrhage, cerebral oedema
Comparison between PWV (cm/s) at 3 months Comparison between PWV (cm/s) between patients and control group
BHI (Breath Holding Index) at day 0, month 1, month 3 BHI measure on middle cerebral arteries by transcranial ultrasound
Trial Locations
- Locations (1)
Nantes University Hospital
🇫🇷Nantes, Loire-Atlantique, France