今天是:2019-11-20 星期三

张天璞医师:该研究尚未获得伦理委员会批准。请于批准后再开始纳入参试者,并与我们联系上传批件。 心血管疾病的系统生物学研究及发病机制的研究
下载XML文档

注册号:

Registration number:

ChiCTR1900026778 

最近更新日期:

Date of Last Refreshed on:

2019-11-05 

注册时间:

Date of Registration:

2019-10-21 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

张天璞医师:该研究尚未获得伦理委员会批准。请于批准后再开始纳入参试者,并与我们联系上传批件。 心血管疾病的系统生物学研究及发病机制的研究 

Public title:

Systematic Biology and Pathogenesis of Cardiovascular Diseases 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

心血管疾病的系统生物学研究及发病机制的研究 

Scientific title:

Systematic Biology and Pathogenesis of Cardiovascular Diseases 

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:

张天璞 

研究负责人:

李遇伯 

Applicant:

Tianpu Zhang 

Study leader:

Yubo Li 

申请注册联系人电话:

Applicant telephone:

+86 18222378277 

研究负责人电话:

Study leader's telephone:

+86 15332130770 

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:

z1179721543@163.com 

研究负责人电子邮件:

Study leader's E-mail:

yaowufenxi001@sina.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:

天津市静海区团泊新城西区鄱阳湖路10号 

研究负责人通讯地址:

天津市静海区团泊新城西区鄱阳湖路10号 

Applicant address:

10 Poyang Lake Road, West Tuanbo New City District, Jinghai District, Tianjin, China  

Study leader's address:

10 Poyang Lake Road, West Tuanbo New City District, Jinghai District, Tianjin, 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:

天津中医药大学 

Applicant's institution:

Tianjin University of Traditional Chinese Medicine  

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

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:

天津中医药大学 

Primary sponsor:

Tianjin University of Traditional Chinese Medicine  

研究实施负责(组长)单位地址:

天津市静海区团泊新城西区鄱阳湖路10号 

Primary sponsor's address:

10 Poyang Lake Road, West Tuanbo New City District, Jinghai District, Tianjin, 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):

天津

市(区县):

Country:

China

Province:

Tianjin

City:

单位(医院):

天津医科大学第二医院

具体地址:

河西区平江道23号

Institution
hospital:

Second Hospital of Tianjin Medical University

Address:

23 Pingjiang Road, Hexi District

国家:

中国

省(直辖市):

天津

市(区县):

Country:

China

Province:

Tianjin

City:

单位(医院):

天津北大医疗海洋石油医院

具体地址:

滨海新区渤海石油路10号

Institution
hospital:

Tianjin Beida Medical Offshore Oil Hospital

Address:

10 Bohai Oil Road, Binhai New Area

经费或物资来源:

天津市第三批人才发展特殊支持计划高层次创新团队  

Source(s) of funding:

Tianjin Development Program for Innovation and Entrepreneurship  

研究疾病:

心血管疾病 

Target disease:

Cardiovascular disease 

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:

探索性研究/预试验 

Study phase:

研究目的:

通过系统生物学技术分析心血管疾病的患者样本与正常受试者间样本中物质的差异,分别找出不同心血管疾病间差异性生物标志物及相关通路,通过对共有标志物和疾病特有标志物进行深层次分析,探究心血管疾病之间的关联机制,揭示关键标志物的生物学功能,为临床对心血管疾病的早期防控和合理用药以及治疗方法的选择提供实验数据。  

Objectives of Study:

The differences of substances in samples of patients with cardiovascular diseases and normal subjects are analyzed through systematic biological technology, and the different biomarkers and related pathways between different cardiovascular diseases are found out respectively. Through in-depth analysis of common markers and disease-specific markers, the correlation mechanism between cardiovascular diseases is explored, and the biological functions of key markers are revealed, providing experimental data for clinical early prevention and control of cardiovascular diseases, rational drug use and selection of treatment methods. 

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:

1)在本院就诊并获得明确诊断的患者; 2)所有检查项目、体征完善; 3)营养状况良好; 4)年龄18岁以上。  

Inclusion criteria

1) Patients who have seen a doctor in our hospital and obtained a clear diagnosis; 2) All inspection items and physical signs are perfect; 3) Good nutrition; 4) Aged Over 18 years.  

排除标准:

1)其他自身免疫疾病个人史及家族史; 2)颈部外伤或手术史、近期放射线接触史; 3)肝炎、结核等慢性病或肿瘤史。 

Exclusion criteria:

1) Personal and family history of other autoimmune diseases; 2) Neck trauma or surgery history, recent radiation exposure history; 3) Chronic diseases such as hepatitis and tuberculosis or tumor history. 

研究实施时间:

Study execute time:

From2019-10-21To 2029-12-31 

干预措施:

Interventions:

组别:

心血管疾病组

样本量:

3000

Group:

Cardiovascular disease group

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

组别:

正常对照组

样本量:

3000

Group:

Normal 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:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津医科大学第二医院 

单位级别:

三甲医院 

Institution
hospital:

The Second Hospital of Tianjin Medical University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津北大医疗海洋石油医院 

单位级别:

二甲医院 

Institution
hospital:

Tianjin Beida Medical Offshore Oil Hospital  

Level of the institution:

Second A Hospital 

测量指标:

Outcomes:

指标中文名:

肌酸激酶

指标类型:

主要指标 

Outcome:

CK

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肌酸激酶同工酶

指标类型:

主要指标 

Outcome:

CK-MB

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

总胆固醇

指标类型:

主要指标 

Outcome:

TC

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

甘油三酯

指标类型:

主要指标 

Outcome:

TG

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

低密度脂蛋白胆固醇

指标类型:

主要指标 

Outcome:

LDL-C

Type:

Primary 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:

主要指标 

Outcome:

HDL-C

Type:

Primary 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T

指标类型:

主要指标 

Outcome:

cTnT

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:

血液

组织:

Sample Name:

Blood

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 80 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):

Not applicable

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):

中国临床试验注册中心http://www.chictr.org.cn/index.aspx

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

China Clinical Trial Registration Centerhttp://www.chictr.org.cn/index.aspx

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:

病例报告表

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

case report form

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-10-21
返回列表