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Endothelial Dysfunction in Reversible Cerebral Vasoconstriction Syndrome

Systemic Endothelial Dysfunction in Reversible Cerebral Vasoconstriction Syndrome : a Case Control Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04463212
Acronym
DESS
Enrollment
62
Registered
2020-07-09
Start date
2021-01-29
Completion date
2024-01-12
Last updated
2024-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reversible Cerebral Vasoconstriction Syndrome

Keywords

Endothelial dysfunction, Reversible cerebral vasoconstriction syndrome, Arterial stiffness, Breath holding index, Pulse wave velocity

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

Interventions

None listed

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

for patients : * 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 Inclusion criteria for control : * Aged from 18 to 80 years old * 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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Compare systemic endothelial function between patient and healthy subject24 hoursBy using Complior, researchers assess systemic endothelial function at inclusion on patient and healthy volunteer person by pulse wave velocity (cm.s-1)

Secondary

MeasureTime frameDescription
Pulse wave velocity (PWV)at day 0, month 1, month 3Pulse wave velocity mesaure from carotid to femoral artery
Relationship between cerebral and systemic endothelial functionat day 0, month 1, month 3Comparison of BHI and VOP evolution
Renal failureDay 0Diminution of creatinin clearance\<100 ml/min/1.73m2
Occurence of stroke or cerebral oedemaat day 0, month 1, month 3Occurrence of ischemic stroke, cerebral haemorrhage, cerebral oedema
BHI (Breath Holding Index)at day 0, month 1, month 3BHI measure on middle cerebral arteries by transcranial ultrasound
Comparison of BHI between patients with or without arterial hypertensionat day 0, month 1, month 3Comparison between middle BHI of patients with arterial hypertension and patients without arterial hypertension
Comparison between PWV (cm/s)at 3 monthsComparison between PWV (cm/s) between patients and control group
Comparison between BHI (cm/s)at 3 monthsComparison between BHI (cm/s) between patients and control group
Comparison of PWV between patients with or without arterial hypertensionat day 0, month 1, month 3Comparison between middle PWV (cm/s) of patients with arterial hypertension and patients without arterial hypertension

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026