DESS: Endothelial Dysfunction in Reversible Cerebral Vasoconstriction Syndrome

Sponsor

Nantes University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04463212

Collaborator

(none)

Enrollment

Location

23.1

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Reversible Cerebral Vasoconstriction Syndrome

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

62 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 29, 2021

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Patient 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 control Subject without SVCR (current and history)

Outcome Measures

Primary Outcome Measures

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

BHI (Breath Holding Index) [at day 0, month 1, month 3]
BHI measure on middle cerebral arteries by transcranial ultrasound
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
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 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 PWV (cm/s) [at 3 months]
Comparison between PWV (cm/s) between patients and control group
Comparison between BHI (cm/s) [at 3 months]
Comparison between BHI (cm/s) between patients and control group

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

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