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基于肺动脉高压多模态影像学的人工智能筛查与评估系统的建立: 临床诊断模型研究
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注册号:

Registration number:

ChiCTR2000036852 

最近更新日期:

Date of Last Refreshed on:

2020-09-20 

注册时间:

Date of Registration:

2020-08-25 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

基于肺动脉高压多模态影像学的人工智能筛查与评估系统的建立: 临床诊断模型研究 

Public title:

Establishment of an artificial intelligence screening and evaluation system based on multimodal imaging of pulmonary arterial hypertension: Study on clinical diagnosis model 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于肺动脉高压多模态影像学的人工智能筛查与评估系统的建立: 临床诊断模型研究 

Scientific title:

Establishment of an artificial intelligence screening and evaluation system based on multimodal imaging of pulmonary arterial hypertension: Study on clinical diagnosis model 

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:

姜蓉 

研究负责人:

史景云 

Applicant:

Rong Jiang 

Study leader:

JIN-Yun Shi 

申请注册联系人电话:

Applicant telephone:

+86 13795493921 

研究负责人电话:

Study leader's telephone:

+86 13671701139 

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:

listening39@163.com 

研究负责人电子邮件:

Study leader's E-mail:

shijingyun89179@126.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:

上海市杨浦区政民路507号 

研究负责人通讯地址:

上海市杨浦区政民路507号 

Applicant address:

507 Zhengmin Road, Yangpu District, Shanghai, China 

Study leader's address:

507 Zhengmin Road, Yangpu District, Shanghai, China 

申请注册联系人邮政编码:

Applicant postcode:

200433 

研究负责人邮政编码:

Study leader's postcode:

200433 

申请人所在单位:

上海市肺科医院 

Applicant's institution:

Shanghai Pulmonary Hospital 

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:

L20-339Y 

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:

上海市肺科医院伦理委员会 

Name of the ethic committee:

The Ethic Committee of Shanghai Pulmonary Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-08-25 

伦理委员会联系人:

张玲 

Contact Name of the ethic committee:

Lin Zhang 

伦理委员会联系地址:

上海市杨浦区政民路507号 

Contact Address of the ethic committee:

507 Zhengmin Road, Yangpu District, Shanghai, 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:

上海市肺科医院 

Primary sponsor:

Shanghai Pulmonary Hospital 

研究实施负责(组长)单位地址:

上海市杨浦区政民路507号 

Primary sponsor's address:

507 Zhengmin Road, Yangpu District, Shanghai, 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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市肺科医院

具体地址:

上海市杨浦区政民路507号

Institution
hospital:

Shanghai Pulmonary Hospital

Address:

507 Zhengmin Road, Yangpu District

经费或物资来源:

无 

Source(s) of funding:

none 

研究疾病:

肺动脉高压 

Target disease:

pulmonary arterial hypertension 

研究疾病代码:

 

Target disease code:

 

研究类型:

诊断试验 

Study type:

Diagnostic test 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

1) 建立肺部影像的人工智能诊断辅助模型和与人工结合的诊断服务系统,针对以金标准RHC确诊的PAH,通过影像学检查,包括胸部X线和 CTPA 影像中提示PAH 的特征,建立快速识别PAH人工智能筛查系统。 2) 建立肺部影像的人工智能评估辅助模型和与人工结合的评估服务系统,对已确诊、并给予PAH靶向药物治疗的PAH 患者进行随访,通过影像学检查,包括胸部X线、CTPA及CMR影像中提示PAH 预后的影像学特征,建立快速评判 PAH 疗效的人工智能评估系统。 

Objectives of Study:

1) to establish the artificial intelligence diagnosis assistant model of pulmonary imaging and the diagnosis service system combined with artificial. Based on PAH diagnosed by gold standard RHC, the characteristics of PAH indicated in chest X-ray and CTPA images were detected by imaging examination, and the artificial intelligence screening system for rapid identification of PAH was established. 2) to establish an artificial intelligence evaluation assistant model of pulmonary imaging and an evaluation service system combined with artificial. The patients with PAH who have been diagnosed and given PAH targeted drug therapy are followed up. Through imaging examination, including chest X-ray, CTPA and CMR images, the imaging characteristics of PAH prognosis are suggested, and the artificial intelligence evaluation system for rapid evaluation of PAH efficacy is established. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

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 

纳入标准:

符合下列所有标准的患者方可纳入本研究: 1) 自愿签署知情同意书; 2) 年龄在18-75岁之间(含18和75岁)者; 3) 按照PAH诊治规范经右心导管检查确诊的第一大类PAH,右心导管:(2) 右心导管:平均肺动脉压(mPAP)≥25 mm Hg ,肺小动脉压(PAWP) ≤ 15mmHg且肺血管阻力(PVR)≥ 3 Wood units (240 dyn?s?cm-5) a) 包括特发性或遗传性PAH; b) 结缔组织疾病相关PAH; c) HIV感染相关PAH; d) 经修复的先天性体肺分流相关PAH; e) 食欲抑制剂或毒素相关PAH。 

Inclusion criteria

1. Signed informed consent voluntarily; 2. Those aged between 18 and 75 years (including 18 and 75 years old); 3. Right heart catheterization: mean pulmonary artery pressure (mPAP) >=25 mm Hg, pulmonary artery wedge pressure (PAWP) <=15 mmHg and pulmonary vascular resistance (PVR) >=3 wood units (240 dyn/s/CM5) (1) idiopathic or hereditary PAH; (2) PAH associated withconnective tissue disease; (3) PAH associted with HIV infection; (4) PAH associated with repaired congental heart disease; (5) PAH associated with appetite inhibitor or toxin. 

排除标准:

1) 其它类型的PH; 2) 患者拒绝签署知情同意书; 3) 缺少胸片X线、CTPA等本院电子影像学资料。 

Exclusion criteria:

1) Other types of pH; 2) Patients refused to sign informed consent; 3) Lack of chest X-ray, CTPA and other electronic imaging data in our hospital. 

研究实施时间:

Study execute time:

From2020-10-01To 2022-09-30 

征募观察对象时间:

Recruiting time:

From2020-10-01To 2022-09-30 

诊断试验:

Diagnostic Tests:

金标准或参考标准(即可准确诊断某疾病的单项方法或多项联合方法,在本研究中用于诊断是否有该病的临床参考标准):

右心导管检查

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

Right heart catheterization

指标试验(即本研究的待评估诊断试验,无论为方法、生物标志物或设备,均请列出名称):

多模态影像学的人工智能

Index test:

multimodal imaging artificial intelligence screening and evaluation system

目标人群(可以是某种疾病患者或正常人群,详细描述其疾病特征,注意应纳入符合分布特点的全序列病例,具有良好的代表性)

肺动脉高压

例数:

Sample size:

1000

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

pulmonary arterial hypertension

容易混淆的疾病人群(即与目标疾病不易区分的一种或多种不同疾病,应避免采用正常人群对照的病例-对照设计):

正常人群

例数:

Sample size:

1000

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

Normal population

研究实施地点:

Countries of recruitment and research settings:

测量指标:

Outcomes:

指标中文名:

基于胸部X光片自动分割肺动脉段

指标类型:

主要指标 

Outcome:

Automatic segmentation of pulmonary artery segments based on chest X-ray films

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

基于胸部CT 的主动脉肺动脉直径比计算

指标类型:

主要指标 

Outcome:

Calculation of aortopulmonary diameter ratio based on chest CT

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

基于胸片的心胸比值估计

指标类型:

主要指标 

Outcome:

Estimation of cardiothoracic ratio based on chest radiograph

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胸部CT右心室左心室短轴直径比

指标类型:

主要指标 

Outcome:

Ratio of right ventricular and left ventricular short axis diameter on chest CT

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

CMR评估心脏形态和功能

指标类型:

主要指标 

Outcome:

Evaluation of cardiac morphology and function by CMR

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:

组织:

NA

Sample Name:

none

Tissue:

NA

人体标本去向

使用后销毁 

说明

NA

Fate of sample:

Destruction after use 

Note:

NA

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 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):

本研究随机方法不适用

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

N/A

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

否No

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12月

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

Dec 2022

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:

数据保管在课题负责单位,采用CRF表格及电子数据库的形式储存

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

The data shall be kept in the responsible unit of the project and stored in the form of CRF form and electronic data

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-08-25
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