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Completed

NCT Number: NCT04463212

Endothelial Dysfunction in Reversible Cerebral Vasoconstriction Syndrome

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Compare systemic endothelial function between patient and healthy subject

    Time frame: 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 outcomes

  1. BHI (Breath Holding Index)

    Time frame: at day 0, month 1, month 3

    BHI measure on middle cerebral arteries by transcranial ultrasound

  2. Pulse wave velocity (PWV)

    Time frame: at day 0, month 1, month 3

    Pulse wave velocity mesaure from carotid to femoral artery

  3. Relationship between cerebral and systemic endothelial function

    Time frame: at day 0, month 1, month 3

    Comparison of BHI and VOP evolution

  4. Renal failure

    Time frame: Day 0

    Diminution of creatinin clearance<100 ml/min/1.73m2

  5. Occurence of stroke or cerebral oedema

    Time frame: at day 0, month 1, month 3

    Occurrence of ischemic stroke, cerebral haemorrhage, cerebral oedema

  6. Comparison of PWV between patients with or without arterial hypertension

    Time frame: at day 0, month 1, month 3

    Comparison between middle PWV (cm/s) of patients with arterial hypertension and patients without arterial hypertension

  7. Comparison of BHI between patients with or without arterial hypertension

    Time frame: at day 0, month 1, month 3

    Comparison between middle BHI of patients with arterial hypertension and patients without arterial hypertension

  8. Comparison between PWV (cm/s)

    Time frame: at 3 months

    Comparison between PWV (cm/s) between patients and control group

  9. Comparison between BHI (cm/s)

    Time frame: at 3 months

    Comparison between BHI (cm/s) between patients and control group

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: DESS

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 9, 2020
Registry last updated
Jan 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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