Endothelial Dysfunction in Reversible Cerebral Vasoconstriction Syndrome (DESS)

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

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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 62

Contacts and Locations

• Study Contact: Name: Annick COULON; Phone Number: 02 53 48 28 35; Email: bp-prom-regl@chu-nantes.fr
• Study Contact Backup: Name: Solène DE GAALON, PhD; Phone Number: 02 40 16 52 12; Email: Solene.DEGAALON@chu-nantes.fr

Study Locations

• France
  • Loire-Atlantique
    • Nantes, Loire-Atlantique, France, 44093
      • Nantes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients and Healthy subjects

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BHI (Breath Holding Index)	BHI measure on middle cerebral arteries by transcranial ultrasound	at day 0, month 1, month 3
Pulse wave velocity (PWV)	Pulse wave velocity mesaure from carotid to femoral artery	at day 0, month 1, month 3
Relationship between cerebral and systemic endothelial function	Comparison of BHI and VOP evolution	at day 0, month 1, month 3
Renal failure	Diminution of creatinin clearance<100 ml/min/1.73m2	Day 0
Occurence of stroke or cerebral oedema	Occurrence of ischemic stroke, cerebral haemorrhage, cerebral oedema	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	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	at day 0, month 1, month 3
Comparison between PWV (cm/s)	Comparison between PWV (cm/s) between patients and control group	at 3 months
Comparison between BHI (cm/s)	Comparison between BHI (cm/s) between patients and control group	at 3 months

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2021
• Primary Completion (Actual): January 12, 2024
• Study Completion (Actual): January 12, 2024

Study Registration Dates

• First Submitted: July 3, 2020
• First Submitted That Met QC Criteria: July 3, 2020
• First Posted (Actual): July 9, 2020

Study Record Updates

• Last Update Posted (Actual): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Endothelial dysfunction; Arterial stiffness; Pulse wave velocity; Reversible cerebral vasoconstriction syndrome; Breath holding index
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: RC20_0280

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No