今天是:2019-12-12 星期四

冠心病预后相关因素分析:一项多中心前瞻性研究
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注册号:

Registration number:

ChiCTR1900024580 

最近更新日期:

Date of Last Refreshed on:

2019-07-18 

注册时间:

Date of Registration:

2019-07-18 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

冠心病预后相关因素分析:一项多中心前瞻性研究 

Public title:

Prognostic factors associated with coronary heart disease: a multicenter, prospective study 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

冠心病预后相关因素分析:一项多中心前瞻性研究 

Scientific title:

Prognostic factors associated with coronary heart disease: a multicenter, prospective study 

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:

郑颖颖 

研究负责人:

张金盈 

Applicant:

Ying-Ying ZHENG 

Study leader:

Jinying Zhang 

申请注册联系人电话:

Applicant telephone:

+86 15214804944 

研究负责人电话:

Study leader's telephone:

+86 13503830283 

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:

zhengying527@163.com 

研究负责人电子邮件:

Study leader's E-mail:

jyzhang@zzu.edu.cn 

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:

河南省郑州市二七区建设东路1号 

研究负责人通讯地址:

河南省郑州市二七区建设东路1号 

Applicant address:

1Jianshe Road East , Erqi District, Zhengzhou, He'nan, China 

Study leader's address:

1Jianshe Road East , Erqi District, Zhengzhou, He'nan, 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:

郑州大学第一附属医院 

Applicant's institution:

The First Affiliated Hospital of Zhengzhou 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-KY-002 

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:

郑州大学第一附属医院科研和临床试验伦理委员会  

Name of the ethic committee:

Ethics Committee of The First Affiliated Hospital of Zhengzhou University  

伦理委员会批准日期:

Date of approved by ethic committee:

2019-01-15 

伦理委员会联系人:

田丽 

Contact Name of the ethic committee:

Li Tian 

伦理委员会联系地址:

河南省郑州市二七区建设东路1号 

Contact Address of the ethic committee:

1Jianshe Road East , Erqi District, Zhengzhou, He'nan, 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:

郑州大学第一附属医院 

Primary sponsor:

The First affiliated hospital of Zhengzhou University  

研究实施负责(组长)单位地址:

河南省郑州市二七区建设东路1号 

Primary sponsor's address:

1 Jianshe Road East, Erqi District, Zhengzhou, He'nan, 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):

河南

市(区县):

Country:

China

Province:

He'nan

City:

单位(医院):

郑州大学第一附属医院

具体地址:

河南省郑州市二七区建设东路1号

Institution
hospital:

The First affiliated hospital of Zhengzhou University

Address:

1 Jianshe Road East, Erqi District, Zhengzhou, He'nan, China

国家:

中国

省(直辖市):

新疆维吾尔自治区

市(区县):

Country:

China

Province:

Xinjiang Uygur Autonomous Region

City:

单位(医院):

新疆医科大学第一附属医院

具体地址:

乌鲁木齐市鲤鱼山南路137号

Institution
hospital:

First Affiliated Hospital of Xinjiang Medical University

Address:

137 Liyushan Road, Urumqi

国家:

中国

省(直辖市):

河南

市(区县):

Country:

China

Province:

He'nan

City:

单位(医院):

南阳市中心医院

具体地址:

河南省南阳市工农路312号

Institution
hospital:

Nanyang Central Hospital

Address:

312 Gongnong Road, Nanyang City, Henan Province

国家:

中国

省(直辖市):

河南

市(区县):

Country:

China

Province:

He'nan

City:

单位(医院):

南阳市第二人民医院

具体地址:

南阳市建设东路66号

Institution
hospital:

Nanyang Second General Hospital

Address:

66 Jiandong Road, Nanyang

国家:

中国

省(直辖市):

河南

市(区县):

Country:

China

Province:

He'nan

City:

单位(医院):

信阳市中心医院

具体地址:

河南省信阳市四一路1号

Institution
hospital:

Xinyang Central Hospital

Address:

1 Siyi Road, Xinyang, He'nan

国家:

中国

省(直辖市):

河南

市(区县):

Country:

China

Province:

He'nan

City:

单位(医院):

驻马店市中心医院

具体地址:

驻马店市中华路西段747号

Institution
hospital:

Zhumadian Central Hospital

Address:

747 West Section of Zhonghua Road, Zhumadian

国家:

中国

省(直辖市):

河南

市(区县):

Country:

China

Province:

He'nan

City:

单位(医院):

三门峡市中心医院

具体地址:

河南省三门峡市崤山路西段

Institution
hospital:

Sanmenxia Central Hospital

Address:

West Siaoshan Road, Sanmenxia, He'nan

国家:

中国

省(直辖市):

河南

市(区县):

Country:

China

Province:

He'nan

City:

单位(医院):

西峡县人民医院

具体地址:

西峡县建设东路376号

Institution
hospital:

Xixia People's Hospital

Address:

376 Jianshan Road East, Xixia County

经费或物资来源:

自筹经费 

Source(s) of funding:

self-financing 

研究疾病:

冠心病 

Target disease:

coronary heart disease 

研究疾病代码:

 

Target disease code:

 

研究类型:

预后研究 

Study type:

Prognosis study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

评价探索与冠心病患者预后相关的多种因素 

Objectives of Study:

Evaluation and exploration of multiple factors related to prognosis of patients with coronary heart disease 

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.年龄≥18岁; 2.冠脉造影证实至少有一支冠状动脉血管狭窄程度>50%。 3.至少有一项冠心病的临床表型:稳定性心绞痛或急性冠脉综合征。 

Inclusion criteria

1. Aged at least 18 years to 80 years; 2. Coronary angiography confirmed at least one coronary artery stenosis> 50%; 3. At least one clinical phenotype of coronary heart disease: stable angina or acute coronary syndrome. 

排除标准:

1.合并严重的心脏瓣膜性疾病; 2.合并严重的先天性心脏病; 3.合并甲状腺功能亢进、贫血等高动力性心脏病; 4.合并肺源性心脏病; 5.合并肥厚性梗阻性心肌病; 6.严重低血压(入组时SBP<90mmHg或DBP<60mmHg); 7.未控制的高血压(PCI术前SBP>160mmHg, 和/或DBP>100mmHg); 8.肝功能不全(定义为ALT或总胆红素大于正常上限的3倍); 9.肾功能不全(定义为血肌酐大于正常上限的1.5倍); 10.高危的出血风险的患者,如血小板减少症,血液系统疾病等 ; 11.活动性消化性溃疡及皮肤溃疡; 12.对氯吡格雷、替格瑞洛、阿司匹林过敏的患者; 13.两周内有心源性休克病史的患者; 14.怀孕及哺乳期妇女,治疗期间不能严格避孕的育龄期妇女。; 15.近3月内参加过其他临床研究者; 16.不具有法律能力或法律能力受限者; 17.研究者认为不适合参加该临床研究的任何情况。  

Exclusion criteria:

1. combined with severe valvular heart disease; 2. combined with severe congenital heart disease; 3. Combined hyperthyroidism, anemia and other high-powered heart disease; 4. with pulmonary heart disease; 5. with hypertrophic obstructive cardiomyopathy; 6. Severe hypotension (SBP <90mmHg or DBP <60mmHg at enrollment); 7. Uncontrolled hypertension (SBP> 160 mmHg before PCI, and / or DBP> 100 mmHg); 8. Liver dysfunction (defined as ALT or total bilirubin is greater than the normal upper limit of 3 times); 9. Renal insufficiency (defined as serum creatinine greater than 1.5 times the normal upper limit); 10. High-risk bleeding patients, such as thrombocytopenia, blood diseases and other diseases; 11. active peptic ulcer and skin ulcers; 12. A patient who is allergic to clopidogrel, tegrellol, or aspirin; 13. Patients with a history of cardiogenic shock within two weeks; 14. pregnant and lactating women, during treatment can not be strict contraception of women of childbearing age; 15. In the past 3 months participated in other clinical researchers; 16. Persons who do not have legal or legal competence; 17. Any condition that the investigator considers unsuitable for participation in the clinical study.  

研究实施时间:

Study execute time:

From2019-08-01To 2022-08-01 

干预措施:

Interventions:

组别:

试验组

样本量:

3000

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):

河南 

市(区县):

 

Country:

China 

Province:

He'nan 

City:

 

单位(医院):

郑州大学第一附属医院 

单位级别:

三级甲等 

Institution
hospital:

The First affiliated hospital of Zhengzhou University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

新疆维吾尔自治区 

市(区县):

 

Country:

China 

Province:

Xinjiang Uygur Autonomous Region  

City:

 

单位(医院):

新疆医科大学第一附属医院 

单位级别:

三级甲等 

Institution
hospital:

First Affiliated Hospital of Xinjiang Medical University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

河南 

市(区县):

 

Country:

China 

Province:

He'nan 

City:

 

单位(医院):

南阳市中心医院 

单位级别:

三级甲等 

Institution
hospital:

Nanyang Central Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

河南 

市(区县):

 

Country:

China 

Province:

He'nan 

City:

 

单位(医院):

南阳市第二人民医院 

单位级别:

三级甲等 

Institution
hospital:

Nanyang Second General Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

河南 

市(区县):

 

Country:

China 

Province:

He'nan 

City:

 

单位(医院):

信阳中心医院 

单位级别:

三级甲等 

Institution
hospital:

Xinyang Central Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

河南 

市(区县):

 

Country:

China 

Province:

He'nan 

City:

 

单位(医院):

驻马店市中心医院 

单位级别:

三级甲等 

Institution
hospital:

Zhumadian Central Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

河南 

市(区县):

 

Country:

China 

Province:

He'nan 

City:

 

单位(医院):

三门峡市中心医院 

单位级别:

三级甲等 

Institution
hospital:

Sanmenxia Central Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

河南 

市(区县):

 

Country:

China 

Province:

He'nan 

City:

 

单位(医院):

西峡县人民医院 

单位级别:

二级甲等 

Institution
hospital:

Xixia People's Hospital  

Level of the institution:

Second A Hospital 

测量指标:

Outcomes:

指标中文名:

全因死亡

指标类型:

主要指标 

Outcome:

all-cause mortality

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心源性死亡

指标类型:

主要指标 

Outcome:

Cardiac mortality

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

脑卒中

指标类型:

主要指标 

Outcome:

stroke

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

BARC2级以上出血事件

指标类型:

主要指标 

Outcome:

BARC2 or more bleeding 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:

再住院

指标类型:

主要指标 

Outcome:

readmission

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

靶血管重建

指标类型:

主要指标 

Outcome:

Target vessel revascularization

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

再发心梗

指标类型:

主要指标 

Outcome:

Recurrent myocardial infarction

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

支架内血栓

指标类型:

主要指标 

Outcome:

Stent thrombosis

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心力衰竭

指标类型:

主要指标 

Outcome:

Heart Failure

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 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):

不涉及随机

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:

即时公开/Real time access

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):

数据完成后6个月内公开

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

Within six months after the data complete

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:

采用excel和epdata数据库保存数据

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

Use excel and epdata database to save data

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-07-18
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