跳至主要内容
临床试验/NCT04204642
NCT04204642招募中不适用

SEarchiNg BiomarkErs Cerebral Amyloid Angiopathy (SENECA): Italian Network for the Study of CAA

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
500
试验地点
1
主要终点
Clinical and neuroradiological phenotype

研究概览

简要总结

Cerebral amyloid angiopathy (CAA) is one of the major types of cerebral small vessel disease, and a leading cause of spontaneous intracerebral hemorrhage and cognitive decline in elderly patients. Although increasingly detected, a number of aspects including the pathophysiology, the clinical and neuroradiological phenotype and the disease course are still under investigation. The incomplete knowledge of the disease limits the implementation of evidence based guidelines on patient's clinical management and the development of treatments able to prevent or reduce disease progression.

The SENECA (SEarchiNg biomarkErs of Cerebral Angiopathy) project is the first Italian multicentre cohort study aimed at better defining the disease natural history and identifying clinical and neuroradiological markers of disease progression. By a multidisciplinary approach and the collection of a large and well phenotyped series and biorepository of CAA patients, the study is ultimately expected to improve the diagnosis and the knowledge of CAA pathophysiological mechanisms.

详细描述

The SENECA is an Italian multicenter network integrating the experience of neurologists, neuroradiologists, neuro-ophthalmologists and biologists and allowing the standardized collection of a well-characterized wide series of sporadic and familial CAA patients.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

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

入选标准

  • All consecutive patients ≥55 years (with the exception of genetic cases), referred to the participating centres, with a diagnosis of possible probable and definite symptomatic or asymptomatic CAA, defined according to the modified Boston neuroradiological criteria, who had undergone at least one brain MRI (mandatory requirement for inclusion of the patient in the study) will be recruited.

排除标准

  • evidence of other causes of cerebral hemorrhage (brain tumors, arteriovenous malformations, aneurysms, cavernous angiomas), contraindications to brain MRI, pregnancy and breastfeeding

结局指标

主要结局

Clinical and neuroradiological phenotype

时间窗: 24 months

description of the phenotypic characteristics of a large population of CAA patients collected in Italy

次要结局

  • severity of the neuroradiological picture(24 months)

研究者

发起方
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
申办方类型
Other
责任方
Sponsor

研究点 (1)

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