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基于新型生物标记物的急性胸痛疾病的精准诊断研究:一项多中心前瞻性队列研究
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注册号:

Registration number:

ChiCTR1900022543 

最近更新日期:

Date of Last Refreshed on:

2019-05-05 

注册时间:

Date of Registration:

2019-04-16 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

基于新型生物标记物的急性胸痛疾病的精准诊断研究:一项多中心前瞻性队列研究 

Public title:

Precise diagnosis of acute chest pain based on new biomarkers: a multicenter prospective cohort study 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于新型生物标记物的急性胸痛疾病的精准诊断研究 

Scientific title:

Precise diagnosis of acute chest pain based on new biomarkers 

研究课题代号(代码):

Study subject ID:

四川省科学技术计划项目(2019JDRC0105);四川大学华西医院学科卓越发展135工程临床研究孵化项目(2018HXFH001) 

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:

李东泽 

研究负责人:

曹钰 

Applicant:

Dongze Li 

Study leader:

Yu Cao 

申请注册联系人电话:

Applicant telephone:

+86 028-85422461 

研究负责人电话:

Study leader's telephone:

+86 028-85422461 

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:

dongze.li@ymail.com 

研究负责人电子邮件:

Study leader's E-mail:

yuyuer@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:

中国四川省成都市武侯区国学巷37号 

研究负责人通讯地址:

中国四川省成都市武侯区国学巷37号 

Applicant address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China 

Study leader's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China 

申请注册联系人邮政编码:

Applicant postcode:

610041 

研究负责人邮政编码:

Study leader's postcode:

610041 

申请人所在单位:

四川大学华西医院 

Applicant's institution:

West China Hospital, Sichuan 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(257) 

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:

四川大学华西医院生物医学伦理分委会 

Name of the ethic committee:

West China Hospital of Sichuan University Biomedical Research Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-04-04 

伦理委员会联系人:

梁茂植 

Contact Name of the ethic committee:

Liang Maozhi 

伦理委员会联系地址:

四川省成都市武侯区国学巷37号 

Contact Address of the ethic committee:

Room 412, Old 8th Teaching Building, West China Hospital, Sichuan University, 37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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:

四川大学华西医院急诊科 

Primary sponsor:

Department of Emergency Medicine, West China Hospital, Sichuan University 

研究实施负责(组长)单位地址:

中国四川省成都市武侯区国学巷37号 

Primary sponsor's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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):

四川

市(区县):

成都市

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

四川大学华西医院

具体地址:

中国四川省成都市武侯区国学巷37号

Institution
hospital:

West China Hospital, Sichuan University

Address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China

经费或物资来源:

四川省科学技术计划项目(2019JDRC0105);四川大学华西医院学科卓越发展135工程临床研究孵化项目(2018HXFH001) 

Source(s) of funding:

Sichuan Science and Technology Program (2019JDRC0105); 135 Project for Disciplines of Excellence-Clinical Research Incubation Project, Sichuan University West China Hospital (2018HXFH001) 

研究疾病:

急性非创伤性胸痛 

Target disease:

Acute non-traumatic chest pain 

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、建立急性非创伤性胸痛患者的临床数据库和血液样本库; 2、以同位素标记相对和绝对定量(isobaric tags for relative and absolute quantitation,iTRAQ)、microRNA和lncRNA芯片技术为基础,寻找急性胸痛高诊断价值的特异性生物标志物,建立高效的急性胸痛疾病联合诊断模型。 

Objectives of Study:

1. Establishment of acute chest pain (ACP) clinical database and blood sample database; 2. Based on isobaric tags for relative and absolute quantification (iTRAQ), microRNA and lncRNA chip technology, look for specific biomarkers with high diagnostic value for acute chest pain, and established an efficient joint diagnostic model for ACP. 

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:

1、经金标准明确诊断的各类急性非创伤性胸痛:1)经主动脉CT血管造影(computed tomography angiography, CTA)明确诊断的急性主动脉夹层(acute aortic dissection,AAD);2)经冠脉造影明确诊断的急性心肌梗死(acute myocardial infarction,AMI);3)经肺动脉CT血管造影(computed tomography pulmonary artery angiography, CTPA)明确诊断的肺栓塞(pulmonary embolism,PE); 2、症状发生到入急诊时间小于24小时。 

Inclusion criteria

1. All kinds of nontraumatic ACP diagnosed by gold standard: 1)acute aortic dissection (AAD) diagnosed by aortic computed tomography angiography (CTA); 2)acute myocardial infarction (AMI) diagnosed by coronary angiography; 3) pulmonary embolism (PE) diagnosed by computed tomography pulmonary artery angiography (CTPA); 2. Patients with less than 24 hours of symptom onset. 

排除标准:

1、肿瘤病史; 2、1月内有感染性疾病史; 3、自身免疫性疾病; 4、糖尿病; 5、妊娠妇女; 6、在入选时间段重复就诊者。 

Exclusion criteria:

1. history of cancer; 2. infectious diseases within 1 month; 3. autoimmune diseases; 4. diabetes mellitus; 5. pregnant women; 6. repeated visits at selected time. 

研究实施时间:

Study execute time:

From2019-08-01To 2022-07-31 

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):

1)AAD:主动脉CTA;2)AMI:冠脉造影;3)PE:CTPA

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):

1)AAD: aortic CTA; 2).AMI: coronary angiography; 3) PE: CTPA.

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):

蛋白组学技术、MicroRNA和lncRNA芯片技术

Index test:

Proteomic technology, MicroRNA and lncRNA chip technology

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)

连续选择2019年8月1日-2021年7月31日于我院和相关协同医院胸痛中心就诊的胸痛患者。

例数:

Sample size:

2364

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):

Acute chest pain patients will be enrolled in the Chest Pain Center of Emergency Department from August 1, 2019 to July 31, 2021.

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):

慢性胸痛疾病,如不稳定心绞痛、X综合症、慢性夹层、慢性肺栓塞。

例数:

Sample size:

100

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

Chronic chest pain, such as unstable angina pectoris, syndrome X, chronic dissection, chronic pulmonary embolism.

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川省 

市(区县):

成都市 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

四川大学华西医院 

单位级别:

三甲医院 

Institution
hospital:

West China Hospital, Sichuan University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

贵州 

市(区县):

遵义 

Country:

China 

Province:

Guizhou 

City:

Zunyi 

单位(医院):

遵义医科大学附属医院 

单位级别:

三甲医院 

Institution
hospital:

Affiliated Hospital of Zunyi Medical University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

泸州 

Country:

China 

Province:

Sichuan 

City:

Luzhou 

单位(医院):

西南医科大学附属医院 

单位级别:

三甲医院 

Institution
hospital:

Affiliated Hospital of Southwest Medical University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

自贡 

Country:

China 

Province:

Sichuan 

City:

Zigong 

单位(医院):

自贡市第四人民医院 

单位级别:

三甲医院 

Institution
hospital:

Zigong Fourth People's Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

南充 

Country:

China 

Province:

Sichuan 

City:

Nanchong 

单位(医院):

川北医学院附属医院 

单位级别:

三甲医院 

Institution
hospital:

Affiliated Hospital of North Sichuan Medical College  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

成都 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

成都上锦南府医院 

单位级别:

三甲医院 

Institution
hospital:

Chengdu Shangjin Nanfu Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

攀枝花 

Country:

China 

Province:

Sichuan 

City:

Panzhihua 

单位(医院):

攀枝花市中心医院 

单位级别:

三甲医院 

Institution
hospital:

Panzhihua Central Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

蛋白标志物

指标类型:

主要指标 

Outcome:

Protein markers

Type:

Primary indicator 

测量时间点:

测量方法:

蛋白组学和ELISA

Measure time point of outcome:

Measure method:

Proteomics and Enzyme-Linked ImmunoSorbent Assay (ELISA)

指标中文名:

MicroRNA标志物

指标类型:

主要指标 

Outcome:

MicroRNA marker

Type:

Primary indicator 

测量时间点:

测量方法:

MicroRNA芯片和q RTPCR

Measure time point of outcome:

Measure method:

MicroRNA chip technology and q RTPCR

指标中文名:

LncRNA标志物

指标类型:

主要指标 

Outcome:

LncRNA marker

Type:

Primary indicator 

测量时间点:

测量方法:

LncRNA芯片和q RTPCR

Measure time point of outcome:

Measure method:

LncRNA chip technology and q RTPCR

指标中文名:

死亡

指标类型:

主要指标 

Outcome:

Death

Type:

Primary indicator 

测量时间点:

测量方法:

随访

Measure time point of outcome:

Measure method:

Follow-up

指标中文名:

心血管不良事件

指标类型:

次要指标 

Outcome:

Cardiovascular adverse events

Type:

Secondary indicator 

测量时间点:

测量方法:

随访

Measure time point of outcome:

Measure method:

Follow-up

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液标本

组织:

外周静脉血

Sample Name:

Blood specimen

Tissue:

Peripheral venous blood

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation 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 years
最大 Max age 90 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):

本研究为诊断性研究,无随机分组必要

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

This study is a diagnostic study and there is no need for randomized grouping.

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):

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):

通过ResMan公开, http://www.medresman.org

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

IPD will be public accessable via ResMan, http://www.medresman.org

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:

数据采集使用CRF表格,数据管理采用电子科研系统。

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

CRF forms are used for data acquisition and electronic system is used for data management.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-04-16
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