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临床试验/NCT03204110
NCT03204110已完成不适用

Non Invasive Assessment of Morphological and Functional Retinal Patterns in Reversible Cerebral Vasoconstriction Syndrome Using Transorbital Echotomography Doppler, Retinography and Retinal Vessel Analyser

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2012年3月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
1
主要终点
The frequency of retinal morphological microvascular abnormalities

研究概览

简要总结

Reversible cerebral vasoconstriction syndrome (RCVS) is a clinico radiological entity characterized by severe headaches (associated or not with neurological complications) during one to 3 weeks, associated with a characteristic 'string and beads' appearance on cerebral arteries, which resolves spontaneously in 3 months. The pathway is unknown. At early stage of the disease (at the first medical consultation) cerebral arterial abnormalities which are necessary for diagnosis are identified in only 20% of patients (brain magnetic resonance imagery (MRI) ,CT scan angiography), appearing with a delay on 2th or 3rd week after the first severe headache..

Retinal artery network is considered to be a window on brain microvasculature by sharing the same embryologic origin and physiopathology. A retinal arteriolar examination at early stage of RCVS could provide non invasively early clue to confirm diagnosis by identifying anatomical change and /or functional abnormalities at the microvascular level, whereas large cerebral artery abnormalities are still normal.

详细描述

Reversible cerebral vasoconstriction syndrome (RCVS) is a clinico radiological entity characterized by severe headaches (associated or not with neurological complications) during one to 3 weeks, associated with a characteristic 'string and beads' appearance on cerebral arteries, which resolves spontaneously in 3 months.

The pathway is unknown. One strong hypothesis is that RCVS is a vasospasm and-vasodilatation disorder starting from small distal cerebral arteries progressing toward to medium sized and large sized cerebral arteries, and disappearing in 3 months.

At early stage of the disease (generally at the first medical consultation round 7 days after the first headache), arterial caliber anomalies cannot be identified on usual investigation (brain MRI, angioscan) in most of the case (80%). They are appearing secondary on repeated angiogram around the 2nd week or 3rd week, permitting to confirm the diagnosis, but with delay. Currently, small cerebral vessel arteries can't be studied directly . Retinal artery network is easy to study. It is considered to be a window on brain microvasculature by sharing the same embryologic origin and physiopathology. The investigators thus hypothesized that retinal arteriolar examination a early stage of RCVS could provide non invasively early clue to confirm diagnosis by identifying anatomical change and /or functional abnormalities at the microvascular level, whereas large cerebral artery abnormalities are still normal.

Hypothesis Arteriolar caliber and vasoreactivity abnormalities at the retinal microvascular level could be an early, non invasive and sensitive diagnostic marker of the RCVS at the first medical consultation in emergency.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • repetitive thunderclap headache highly suggestive of RCVS (clinical syndrome)
  • maximum delay of ten days between the first thunderclap headache (qualifying event) and patient's inclusion.
  • informed written consent

排除标准

  • intracranial aneurism on angiography (Brain MRI or angioscan)
  • severe atheroma with cervical stenosis up to 80%
  • medical history of diabetes and/or hypertension

结局指标

主要结局

The frequency of retinal morphological microvascular abnormalities

时间窗: < 10 days

The frequency of retinal abnormalities will be described at early stage of RCVS (\< 10 days following the first thunderclap headache = qualifying event) • by measuring the retinal arteriolar caliber at baseline (micrometer, µm)

The frequency of retinal functional vascular abnormalities

时间窗: < 10 days

The frequency and type of retinal abnormalities will be described at early stage of RCVS (\< 10 days following the first thunderclap headache = qualifying event) • by measuring the meanflow value in central retinal artery (cm/s), ciliar arteries (cm/s) and ophthalmic arteries(cm/s) at baseline • by measuring the diameter variation of retinal microvascular network (% of variation) during a vasoreactivity test (flicker stimulation with RVA)

The type of retinal morphological microvascular abnormalities

时间窗: < 10 days

The type of retinal abnormalities will be described at early stage of RCVS (\< 10 days following the first thunderclap headache = qualifying event) • by measuring the retinal arteriolar caliber at baseline (micrometer, µm)

The type of retinal functional vascular abnormalities

时间窗: < 10 days

The type of retinal abnormalities will be described at early stage of RCVS (\< 10 days following the first thunderclap headache = qualifying event) • by measuring the meanflow value in central retinal artery (cm/s), ciliar arteries (cm/s) and ophthalmic arteries(cm/s) at baseline • by measuring the diameter variation of retinal microvascular network (% of variation) during a vasoreactivity test (flicker stimulation with RVA)

次要结局

  • The kinetic of morphological retinal abnormalities during RCVS(at Day10, Day14, Day21 and Day 90)
  • the kinetic of morphological patterns on Brain RMI during RCVS course during RCVS course(at Day10, Day 14, Day 21 and Day 90)
  • the kinetic of functional patterns on cervico transcranial duplex evaluation during RCVS course(at Day10, Day 14, Day 21 and Day 90)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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