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【ChiCTR2000028999】Early detection of dementia in subjects with type 2 diabetes based on white matter hyperintensities estimated by automatic retinal image analysis (ARIA) method

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基本信息

登记号

ChiCTR2000028999

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2020-01-11

临床申请受理号

靶点

适应症

癡呆症

试验通俗题目

Early detection of dementia in subjects with type 2 diabetes based on white matter hyperintensities estimated by automatic retinal image analysis (ARIA) method

试验专业题目

Early detection of dementia in subjects with type 2 diabetes based on white matter hyperintensities estimated by automatic retinal image analysis (ARIA) method

申办单位信息

申请人联系人

申请人名称

联系人邮箱

联系人邮编

联系人通讯地址

临床试验信息

试验目的

1. Validate and fine-tune the estimate of ARIA-WMH using MRI as gold standard. We will offer a MRI scan for the control subjects who have ARIA-WMH values falling on the top 10%-15% range (n=150). We will also randomly select 10%-15% subjects from the rest of the control group for comparison and evaluate the accuracy of the ARIA-WMH estimates as compared to the MRI values (n=150); 2. Estimate the grade and volume of white matter hyperintensities (WMH) using the automatic retinal image analysis (ARIA) method for both type 2 diabetes and control subjects. Compare the mean and proportions of grade 3 WMH among the two type 2 diabetes groups (both Hong Kong and UK) and the control group; 3. In the two diabetes groups, evaluate if there are significant associations between WMH and risks of other diabetic complications, including stroke, coronary heart disease, chronic kidney disease, and neuropathy.

试验分类

试验类型

析因分组（即根据危险因素或暴露因素分组）

试验分期

其它

随机化

Nil

盲法

N/A

试验项目经费来源

ITF GRANT

试验范围

目标入组人数

1000;2000

实际入组人数

第一例入组时间

2020-01-15

试验终止时间

2022-07-31

是否属于一致性

入选标准

Aged >=18 years; Objective 1: Type 2 diabetes patients from Diabetic Eye Screening Wales (DESW) in United Kingdom and already took retinal images; Objective 2: Type 2 diabetes patients from the Risk Assessment and Management Programme (RAMP) in Hong King and already took retinal images; Control group: Willing to sign the informed consent form; Willing to comply with procedures required in the protocol.；

排除标准

Poor retinal images quality that cannot be used; Control group only: Subjects with other eye diseases which are not suitable for retinal imaging, such as severe cataract, glaucoma, atretopsia, corneal plague. Subjects are distress with flashlight or have experience with photosensitive seizure.；

研究者信息

研究负责人姓名

试验机构

The Centre for Clinical Research and Biostatistics, The Chinese University of Hong Kong

研究负责人电话

研究负责人邮箱

研究负责人邮编

联系人通讯地址

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