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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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注册号：

Registration number：

 ChiCTR2000028999 

最近更新日期：

Date of Last Refreshed on：

 2020-01-11 11:03:46 

注册时间：

Date of Registration：

 2020-01-11 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

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

Public title：

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

注册题目简写：

English Acronym：

研究课题的正式科学名称：

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

Scientific title：

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

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

Maria LAI 

研究负责人：

Prof. Benny Zee 

Applicant：

Maria LAI 

Study leader：

Prof. Benny Zee 

申请注册联系人电话：

Applicant telephone：

 +852 22528865

研究负责人电话：

Study leader's
telephone：

+852 22528865

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 marialai@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 bzee@cuhk.edu.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

Rm 501-502, JC School of Public Health Bldg., Prince of Wales Hospital, Shatin, Hong Kong, China

研究负责人通讯地址：

Rm 501-502, JC School of Public Health Bldg., Prince of Wales Hospital, Shatin, Hong Kong, China

Applicant address：

Rm 501-502, JC School of Public Health Bldg., Prince of Wales Hospital, Shatin, Hong Kong, China

Study leader's address：

Rm 501-502, JC School of Public Health Bldg., Prince of Wales Hospital, Shatin, Hong Kong, China

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

香港中文大學

Applicant's institution：

The Chinese University of Hong Kong

研究负责人所在单位：

香港中文大學

Affiliation of the Leader：

The Chinese University of Hong Kong

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2019.184

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

香港中文大學-新界東醫院聯網臨床研究倫理聯席委員會

Name of the ethic committee：

The Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2019-04-02 00:00:00

伦理委员会联系人：

Envy Lee

Contact Name of the ethic committee：

Envy Lee

伦理委员会联系地址：

中國香港特別行政區新界沙田威爾士親王醫院呂志和臨床科學大樓8/F

Contact Address of the ethic committee：

8/F Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 35053935

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

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

Primary sponsor：

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

研究实施负责（组长）单位地址：

Rm 501-502, JC School of Public Health Bldg., Prince of Wales Hospital, Shatin, Hong Kong, China

Primary sponsor's address：

Rm 501-502, JC School of Public Health Bldg., Prince of Wales Hospital, Shatin, Hong Kong, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

United Kingdom

省(直辖市)：

Swansea

市(区县)：

Country：

United Kingdom

Province：

Swansea

City：

单位(医院)：

Swansea University

具体地址：

Singleton Park Swansea SA2 8PP Wales, UK

Institution
hospital：

Swansea University

Address：

Singleton Park Swansea SA2 8PP Wales, UK

经费或物资来源：

ITF GRANT

Source(s) of funding：

ITF GRANT

研究疾病：

癡呆症  

Target disease：

Dementia

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

析因分组（即根据危险因素或暴露因素分组） 

Study design：

Factorial 

研究目的：

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.  

Objectives of Study：

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.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

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.

Exclusion criteria：

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.

研究实施时间：

Study execute time：

从 From 2020-01-15 00:00:00至 To 2022-07-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2020-01-15 00:00:00 至 To 2022-01-31 00:00:00

干预措施：

Interventions：

组别：

Case series (UK)

样本量：

 2000

Group：

Case series (UK)

Sample size：

干预措施：

Nil

干预措施代码：

Intervention：

Nil

Intervention code：

组别：

Case series (Hong Kong)

样本量：

 1000

Group：

Case series (Hong Kong)

Sample size：

干预措施：

Nil

干预措施代码：

Intervention：

Nil

Intervention code：

组别：

Control group

样本量：

 1000

Group：

Control group

Sample size：

干预措施：

Nil

干预措施代码：

Intervention：

Nil

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

Hong Kong

单位(医院)：

 香港中文大學 

单位级别：

 大學 

Institution
hospital：

The Chinese University of Hong Kong

Level of the institution：

University

国家：

 United Kingdom

省(直辖市)：

 Swansea 

市(区县)：

  

Country：

United Kingdom

Province：

Swansea

City：

单位(医院)：

 Swansea University 

单位级别：

 大學 

Institution
hospital：

Swansea University

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

Estimation of White matter hyperintensities (WMH) grade and volume

指标类型：

主要指标

Outcome：

Estimation of White matter hyperintensities (WMH) grade and volume

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

Nil

组织：

Sample Name：

Nil

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

Nil

Randomization Procedure (please state who generates the random number sequence and by what method)：

Nil

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

N/A

Blinding：

N/A

是否共享原始数据：

IPD sharing

是Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

IPD will not be shared

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

IPD will not be shared

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

Only subject numbers and initials will be indicated on the images record and case report form for data collections and analysis. No subjects’ identification will be obtained from the sites. The study will be conducted in compliance with the principles of the Declaration of Helsinki.

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Only subject numbers and initials will be indicated on the images record and case report form for data collections and analysis. No subjects’ identification will be obtained from the sites. The study will be conducted in compliance with the principles of the Declaration of Helsinki.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2020-01-11 11:03:46
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