Endothelial Dysfunction in Reversible Cerebral Vasoconstriction Syndrome
Keywords
Abstract
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
Dates
| Last Verified: | 06/30/2020 |
| First Submitted: | 07/02/2020 |
| Estimated Enrollment Submitted: | 07/02/2020 |
| First Posted: | 07/08/2020 |
| Last Update Submitted: | 07/23/2020 |
| Last Update Posted: | 07/27/2020 |
| Actual Study Start Date: | 09/30/2020 |
| Estimated Primary Completion Date: | 12/31/2022 |
| Estimated Study Completion Date: | 12/31/2022 |
Condition or disease
Phase
Arm Groups
| 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) |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Sampling method | Non-Probability Sample |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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 |
Outcome
Primary Outcome Measures
1. Compare systemic endothelial function between patient and healthy subject [24 hours]
Secondary Outcome Measures
1. BHI (Breath Holding Index) [at day 0, month 1, month 3]
2. Pulse wave velocity (PWV) [at day 0, month 1, month 3]
3. Relationship between cerebral and systemic endothelial function [at day 0, month 1, month 3]
4. Renal failure [Day 0]
5. Occurence of stroke or cerebral oedema [at day 0, month 1, month 3]
6. Comparison of PWV between patients with or without arterial hypertension [at day 0, month 1, month 3]
7. Comparison of BHI between patients with or without arterial hypertension [at day 0, month 1, month 3]
8. Comparison between PWV (cm/s) [at 3 months]
9. Comparison between BHI (cm/s) [at 3 months]
