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临床试验/NCT05015244
NCT05015244Unknown不适用

Impact of Von Willebrand Factor-platelet Aggregates in Patients With Type 2B Disease

University Hospital, Caen2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2019年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
5
试验地点
2
主要终点
Rate of cerebral lesions in patients with type 2B disease

研究概览

简要总结

The working hypothesis is that patients with Von Willebrand Disease-type 2B may have neurological symptoms due to the chronic formation of platelets/Von Willebrand Factor aggregates. Interestingly, several patients present nonspecific neurological symptoms (nystagmus, headaches, memory disorder, ...) which may be associated with cerebral microangiopathy and chronic microvessel inflammation secondary to Von Willebrand Disease-type 2B due to chronic exposure to Von Willebrand Factor-platelets complexes.

详细描述

Investigator will use an extensive series of neuropsychological tests that cover virtually all cognitive domains. A measurement of global cognitive function will be assessed by the Mini Mental State Examination (MMSE). The verbal memory function will be assessed by the Rey Auditory Verbal Learning Test (RAVLT). Visuospatial memory will be administered by the Rey's Complex Figure Test (RCFT). To evaluate speed of mental processes, Stroop test (three subtasks), the Paper and Pencil Memory Scanning Task (four subtasks), the Symbol-Digit Substitution Task will be used. To evaluate attention, the verbal series attention test (VSAT) will be used. To register subjective cognitive failures investigator will administer the Cognitive failures questionnaire (CFQ). The neurological evaluation will be completed with 3T (Tesla) Magnetic Resonance Imaging (MRI) with different MRI sequences including T1 3D SPACE, FLAIR 3D , 3D SWI (Susceptibility weighted imaging) and 2D EPI (Echo Planar Imaging) to address the presence of cerebral small vessel disease. The presence of each of the four MRI markers for cerebral small vessel disease (white matter hyperintensities, lacunes, cerebral microbleeds and perivascular spaces will be addressed.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with type 2B disease
  • neurological signs
  • signature of inform consent

排除标准

  • contraindication for MRI
  • Pregnant women
  • other hemorrhagic disease

结局指标

主要结局

Rate of cerebral lesions in patients with type 2B disease

时间窗: at the inclusion

Analysis of MRI sequences and % of patients with cerebral lesions

次要结局

  • Verbal memory function evaluation(at the inclusion)
  • Attention evaluation(at the inclusion)
  • Subjective cognitive failures evaluation(at the inclusion)
  • Visuospatial memory evaluation(at the inclusion)
  • Global cognitive function evaluation(at the inclusion)
  • Speed of mental processes evaluation(at the inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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