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肺动脉高压精准诊断技术与评价体系构建
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注册号:

Registration number:

ChiCTR-DDD-16009406 

最近更新日期:

Date of Last Refreshed on:

2016-10-14 

注册时间:

Date of Registration:

2016-10-14 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

肺动脉高压精准诊断技术与评价体系构建 

Public title:

System Construction of Precious Diagnosis and Evaluation for Pulmonary Arterial Hpyertension 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

肺动脉高压精准诊断技术与评价体系构建 

Scientific title:

System Construction of Precious Diagnosis and Evaluation for Pulmonary Arterial Hpyertension 

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:

刘锦铭 

Applicant:

jiang Rong 

Study leader:

Liu jin-ming 

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 13818181063 

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:

jinmingliu2007@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:

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 Rd., YangPu district, Shanghai, 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:

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:

K16-293 

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:

Institutional Ethics Committee of Shanghai Pulmonary Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-10-13 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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

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, Shanghai, China

经费或物资来源:

上海申康医院发展中心 

Source(s) of funding:

Shanghai shengkang hospital development center  

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:

诊断试验新技术临床试验 

Study phase:

Diagnostic New Technique Clincal Study 

研究目的:

1.探讨血浆/血清生物标志物、Echo、CPET、6MWD、WHO FC、CTPA和CMR等无创性检查在评估PAH危险程度及预后转归中的价值。 2.在排除已知突变IPAH患者中,采用全基因组关联SNP分析方法,发现与PAH表型相关SNP位点;通过这些SNP位点所在功能基因的深入研究,揭示新的PAH遗传易感因素及致病机制。 3.构建一套由血浆/血清生化标志物、基因表型、Echo、SE、CPET、6MWD、WHO FC、CTPA和CMR等组成的综合诊断模型,以无创性检查精准且综合性诊断和评估PAH。 

Objectives of Study:

1.To explore the value of plasma / serum biomarkers, Echo, CPET, 6MWD, FC, WHO, CTPA and CMR in assessing the risk of PAH and prognosis. 2.After exclusion of known mutations in IPAH patients, Genome-wide association analysis method of SNP was found the phenotype of PAH SNP loci; To reveal PAH new genetic predisposing factors and pathogenic mechanism by studying these SNP loci of functional genes,. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

诊断试验诊断准确性 

Study design:

Diagnostic test for accuracy 

纳入标准:

第一大类肺动脉高压 

Inclusion criteria

Group 1 Pulmonary arterial hypertension 

排除标准:

第二、第三、第四、第五类肺动脉高压 

Exclusion criteria:

Group 2 Pulmonary hypertension Group 3 Pulmonary hypertension Group 4 Pulmonary hypertension Group 5 Pulmonary hypertension 

研究实施时间:

Study execute time:

From2016-11-01To 2019-12-31 

征募观察对象时间:

Recruiting time:

From2016-11-01To 2019-12-31 

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):

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):

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):

Index test:

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)

例数:

Sample size:

0

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):

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):

例数:

Sample size:

0

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

研究实施地点:

Countries of recruitment and research settings:

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 

单位级别:

三级甲等 

Institution
hospital:

Shanghai Pulmonary Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

临床恶化事件

指标类型:

主要指标 

Outcome:

clinical worsening events

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

右心导管检查

指标类型:

主要指标 

Outcome:

right heart catherization

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

运动心肺测试

指标类型:

主要指标 

Outcome:

cardiopulmonary exerise testing

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

六分钟步行距离

指标类型:

主要指标 

Outcome:

six-minute walking distance

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

负荷心脏超声

指标类型:

主要指标 

Outcome:

stresss-echocardiography

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺血管增强CT

指标类型:

主要指标 

Outcome:

CTPA

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心脏磁共振

指标类型:

主要指标 

Outcome:

CMR

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生化标志物

指标类型:

主要指标 

Outcome:

biomarker

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

亚硝酸盐

指标类型:

次要指标 

Outcome:

Nitrite

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胆红素

指标类型:

次要指标 

Outcome:

Bilirubin

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

高密度脂蛋白胆固醇

指标类型:

次要指标 

Outcome:

high-density lipoprotein cholesterol

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

异前列烷

指标类型:

次要指标 

Outcome:

8-Isoprostane F2α

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

异前列烷

指标类型:

次要指标 

Outcome:

8-Isoprostane F2α

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿酸

指标类型:

次要指标 

Outcome:

Uric acid

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生长分化因子

指标类型:

次要指标 

Outcome:

growth differentiation Factor-15

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

C反应蛋白

指标类型:

次要指标 

Outcome:

C-reactive protein

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

D-二聚体

指标类型:

次要指标 

Outcome:

D-dimer

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血管性血友病因子

指标类型:

次要指标 

Outcome:

von Willebtand Factor

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

内皮素受体-1

指标类型:

次要指标 

Outcome:

ET-1

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肌钙蛋白

指标类型:

次要指标 

Outcome:

Troponin

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

氨基末端脑钠肽前体

指标类型:

次要指标 

Outcome:

NT-proBNP

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

全基因组SNP分型

指标类型:

次要指标 

Outcome:

SNP genotype

Type:

Secondary 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:

Sample Name:

Blood

Tissue:

blood

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 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):

不适用

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

N/A

盲法:

Blinding:

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

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):

2020年6月

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

2020 June

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:

data saved in responsible hospital by CRF and saved in computer with follow up specialized software.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-10-14
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