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临床试验/NCT05308823
NCT05308823Unknown不适用

Outcome of Cerebral Venous Sinuses Stenting on Idiopathic Intracranial Hypertension

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年3月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
Improvement of headache

研究概览

简要总结

The aim of the work is to asses the positive effect of stenotic sinus segment stenting on idiopathic intracranial hypertension with headache and papilloedema.

详细描述

Participants The study will include group of patients with an established diagnosis of idiopathic intracranial hypertenton meeting our inclusion criteria and will admitted to Al-Azher Univerity Hospitals (Al-Hussien and Bab El-Shaeria) after informed consent from them. The recruitment will take place after approval from the Ethics Committee and the University Council.

  • They are selected according to The modified Dandy Criteria to Diagnose IIH:
  1. Grade II paplledema .
  2. normal neurological examination except for six nerve palsy.
  3. neuroimaging criteria of normal brain parenchyma without evidence of hydrocephalus, mass or structural lesion and no abnormal meningeal enhancement on MRI.
  4. normal CSF composition.
  5. elevated lumbar puncture opening pressure, defined as greater than or equal to 250 mmH2O in adults (7).
  • Exclusion criteria included:
  1. Age less than orequal to 18 years.
  2. creatinine .1.5 mg/dL.
  3. severe allergic reaction to iodine contrast.
  4. contraindication to general anesthesia, use of aspirin, clopidogrel or anticoagulants, thrombophilic disorder or anticardiolipin syndrome.
  5. dural arteriovenous fistula or other arteriovenous lesion affecting cortical venous flow.
  6. pregnancy.
  7. Blood pressure must be measured to exclude malignant hypertension, as defined as a diastolic blood pressure greater than or equal to 120 mm Hg or systolic blood pressure greater than or equal to 180 mm Hg(17).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Grade II paplledema .
  • normal neurological examination except for six nerve palsy.
  • neuroimaging criteria of normal brain parenchyma without evidence of hydrocephalus, mass or structural lesion and no abnormal meningeal enhancement on MRI.
  • normal CSF composition.
  • elevated lumbar puncture opening pressure, defined as greater than or equal to 250 mmH2O in adults

排除标准

  • Age less than to 18 years.
  • creatinine .1.5 mg/dL.
  • severe allergic reaction to iodine contrast. 4.contraindication to general anesthesia, use of aspirin, clopidogrel or anticoagulants, thrombophilic disorder or anticardiolipin syndrome.
  • dural arteriovenous fistula or other arteriovenous lesion affecting cortical venous flow.

结局指标

主要结局

Improvement of headache

时间窗: 3 months after intervention

Headache Impact Test (HIT-6) questionnaire.

Change in papillodema

时间窗: 3 months after intervention

Frisen scale in grading of papilledema evaluation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alwathekbellah Ihab Ahmed Elsayed

Doctor

Al-Azhar University

研究点 (1)

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