今天是:2019-09-17 星期二

颈动脉超声诊断人工智能系统的开发和临床研究
下载XML文档

注册号:

Registration number:

ChiCTR1900024900 

最近更新日期:

Date of Last Refreshed on:

2019-08-03 

注册时间:

Date of Registration:

2019-08-03 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

颈动脉超声诊断人工智能系统的开发和临床研究 

Public title:

Clinical trial of carotid artery ultrasound by artificial intelligence 

注册题目简写:

智能颈动脉 

English Acronym:

AI-CAU 

研究课题的正式科学名称:

颈动脉超声诊断人工智能系统—血管医生的开发和应用 

Scientific title:

Development and application of carotid artery ultrasound by artificial intelligence 

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:

牟芸 

研究负责人:

牟芸 

Applicant:

MOU YUN 

Study leader:

MOU YUN 

申请注册联系人电话:

Applicant telephone:

+86 13857122372 

研究负责人电话:

Study leader's telephone:

+86 13857122372 

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:

xuyuntin@163.com 

研究负责人电子邮件:

Study leader's E-mail:

xuyuntin@163.com 

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:

杭州市庆春路79号浙一医院二号楼四楼超声科 

研究负责人通讯地址:

杭州市庆春路79号浙一医院二号楼四楼超声科 

Applicant address:

79 Qingchun Road, Hangzhou, Zhejiang, China 

Study leader's address:

79 Qingchun Road, Hangzhou, Zhejiang, 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:

浙江大学医学院附属第一医院 

Applicant's institution:

The First Affiliated Hospital, School of Medicine, Zhejiang University 

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科研快审第1025号 

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:

浙江大学医学院附属第一医院 

Name of the ethic committee:

The First Affiliated Hospital, College of Medicine, Zhejiang University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-07-01 

伦理委员会联系人:

郑敏 

Contact Name of the ethic committee:

Zheng Min 

伦理委员会联系地址:

杭州市庆春路79号 

Contact Address of the ethic committee:

79 Qingchun Road, Hangzhou, Zhejiang, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

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:

浙江大学医学院附属第一医院 

Primary sponsor:

The First Affiliated Hospital, College of Medicine, Zhejiang University 

研究实施负责(组长)单位地址:

杭州市庆春路79号 

Primary sponsor's address:

79 Qingchun Road, Hangzhou, Zhejiang, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

浙江省

市(区县):

Country:

China

Province:

Zhejiang

City:

单位(医院):

浙江大学医学院附属第一医院

具体地址:

杭州市庆春路79号

Institution
hospital:

The First Affiliated Hospital, College of Medicine, Zhejiang University

Address:

79 Qingchun Road, Hangzhou

经费或物资来源:

浙江省自然科学基金 

Source(s) of funding:

Zhejiang Provincial Natural Sicence Foundation 

研究疾病:

颈动脉硬化 

Target disease:

Carotid arteriosclerosis 

研究疾病代码:

 

Target disease code:

 

研究类型:

基础科学研究 

Study type:

Basic Science 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

1)以颈动脉为窗口,超声采集颈动脉图像的基础上,开发中国人完全知识产权的人工智能动脉分析系统。 2)建立中国人颈动脉内中膜厚度大数据库。 3)在此基础上,通过机器智能学习分析,建立一套根据机器自我识别颈动脉内中膜厚度来判断人体血管年龄的识别系统。 4)系统实现智能分析,智能判断及智能对照,适用所有超声机型,最后可以与仪器整合。 系统最终可以实现基础单位精准IMT扫查,斑块性质判断,以及后续就医指导,形成完全知识产权的“血管医生”,应用前景广泛。 

Objectives of Study:

1}An artificial intelligence artery analysis system with Chinese complete intellectual property rights is developed based on the carotid artery image acquisition by ultrasound. 2}To establish a large database of carotid intima thickness in Chinese. 3)On this basis, a recognition system was established to determine the age of human blood vessels according to the thickness of carotid artery by machine intelligent learning analysis. 4)The system realizes intelligent analysis, intelligent judgment and intelligent comparison, applicable to all ultrasonic models, and finally can be integrated with the instrument. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

健康组:年龄25-75岁,正常血压,正常总胆固醇(实验室界限内的血脂值)。控制组:年龄从25岁到75岁,控制高血压(血压水平<140/90 mm Hg)、或控制性高脂蛋白血症(实验室界限内的血脂值)。患者组:已发生心力衰竭,心肌梗死,脑卒中或短暂性脑缺血发作(TIA)中任意一项或以上。 

Inclusion criteria

Healthy group: 25-75 years old, normal blood pressure, normal total cholesterol (lipids within laboratory boundaries). Control group: ages 25 to 75, controlled hypertension (blood pressure level < 140/90 mm Hg), or controlled hyperlipoproteinemia (lipid profile within laboratory boundaries). Patients: Heart failure, myocardial infarction, stroke, or transient ischemic attack (TIA) has occurred in any one or more cases. 

排除标准:

肿瘤患者,循环系统以外慢性疾病患者和酗酒者。 

Exclusion criteria:

Patients with cancer, chronic diseases outside the circulatory system and alcoholics 

研究实施时间:

Study execute time:

From2019-12-01To 2021-12-31 

干预措施:

Interventions:

组别:

Case series

样本量:

5000

Group:

Case series

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:

中国 

省(直辖市):

浙江省 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江大学医学院附属第一医院 

单位级别:

三甲医院 

Institution
hospital:

The First Affiliated Hospital, College of Medicine, Zhejiang University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

连续入组

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

N/A

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

2022年,以CRF表的形式公开

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

the year of 2021,CRF table

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:

病人编号 病人类型 检查时间 检查号 病人 姓名缩写 性别 年龄 审核医生 审核时间 门诊住院号 出生日期 1 2 3 4 5 6 7 8 9 10 11 12 13 14

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

number, type, examination time , examination digit, name abbreviation, sex, age ,audit doctor,audit time, out-patient inpatient, date of birth

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-08-03
返回列表