Endothelial Dysfunction in Reversible Cerebral Vasoconstriction Syndrome

NCT04463212 | Completed

• 1 other identifier: RC20_0280
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Reversible Cerebral Vasoconstriction Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• BHI (Breath Holding Index)

  at day 0, month 1, month 3

• Pulse wave velocity (PWV)

  at day 0, month 1, month 3

• Relationship between cerebral and systemic endothelial function

  at day 0, month 1, month 3

• Renal failure

  Day 0

• Occurence of stroke or cerebral oedema

  at day 0, month 1, month 3

Study Arms (2)

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)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients and Healthy subjects

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• \- No reversibility at 3 months
• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

Location

Related Publications (1)

• Constant Dit Beaufils P, Barbin L, Pere M, Colleu C, Connault J, Preterre C, Guillon B, de Gaalon S. Systemic Arterial Stiffness in Reversible Cerebral Vasoconstriction Syndrome: A Prospective Case-Control Study. Eur J Neurol. 2026 Feb;33(2):e70495. doi: 10.1111/ene.70495.

  PMID: 41589411 DERIVED

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2020
• First Posted: July 9, 2020
• Study Start: January 29, 2021
• Primary Completion: January 12, 2024
• Study Completion: January 12, 2024
• Last Updated: January 24, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)