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Chinese Atrial Fibrillation Registry
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注册号:

Registration number:

ChiCTR-OCH-13003729 

最近更新日期:

Date of Last Refreshed on:

2016-05-02 

注册时间:

Date of Registration:

2013-10-22 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

中国心房颤动登记研究 

Public title:

Chinese Atrial Fibrillation Registry 

注册题目简写:

 

English Acronym:

CAFR 

研究课题的正式科学名称:

心房颤动治疗规范与技术优化研究 

Scientific title:

Treatment Standard and Technology Optimization Research on Atrial Fibrillation 

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:

吴嘉慧 

研究负责人:

马长生 

Applicant:

Jiahui Wu 

Study leader:

Changsheng Ma 

申请注册联系人电话:

Applicant telephone:

+86 010-84005361 

研究负责人电话:

Study leader's telephone:

+86 010-64456078 

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:

wujiahui1998@163.com 

研究负责人电子邮件:

Study leader's E-mail:

chshma@vip.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:

北京市朝阳区 安贞路 2号 

研究负责人通讯地址:

北京市朝阳区 安贞路 2号 

Applicant address:

Department of Cardiology, 2 Anzhen Road, Chaoyang District, Beijing 

Study leader's address:

Department of Cardiology, 2 Anzhen Road, Chaoyang District, Beijing 

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:

北京市安贞医院 

Applicant's institution:

Beijing Anzhen 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:

伦理备案 

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:

北京安贞医院伦理委员会 

Name of the ethic committee:

Beijin Anzhen Hospital ethics committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2011-06-10 

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:

首都医科大学附属北京安贞医院 

Primary sponsor:

Beijin Anzhen Hospital, Capital Medical University 

研究实施负责(组长)单位地址:

北京市朝阳区 安贞路 2号 

Primary sponsor's address:

2 Anzhen Road, Chaoyang District, Beijing 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

北京市科委 

Source(s) of funding:

Beijing Scientifc Association 

研究疾病:

心房颤动 

Target disease:

artrial fibrillation 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

通过分析中国房颤患者队列的CHADS2、CHA2DS2-VAsc评分来建立中国房颤患者的危险分层模型 

Objectives of Study:

To establish the risk stratification model most fit for Chinese AF patients by validating CHADS2 and CHA2DS2-VASc score using Chinese AF cohort. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

1.年龄大于18岁。 2.近6个月内有确切的心电图或者Holter记录房颤。 

Inclusion criteria

1. Aged >=18 years old; 2. In the past 6 months, having definitely recorded outbreak of AF by means of electrocardiogram or Holter ECG. 

排除标准:

1.可逆原因引起的一过性房颤。 2.合并其它疾患,预计生存时间小于1年。 3.合并瓣膜疾病,以及任何瓣膜中度到重度狭窄或关闭不全。 

Exclusion criteria:

1. Transitorily AF caused by reversible reasons; 2. Combined with other diseases and life expectancy is < 1 year; 3. Combined with valvular heart disease and any one of the valves is narrow or incompetence with intermediate grade or higher grade; 4. Having not signed the informed consent and do not agreed to take part in follow-up study. 

研究实施时间:

Study execute time:

From2011-06-10To 2013-12-31 

征募观察对象时间:

Recruiting time:

From2011-06-10To 2013-12-31 

干预措施:

Interventions:

组别:

one cohort

样本量:

10000

Group:

one cohort

Sample size:

干预措施:

NA

干预措施代码:

Intervention:

NA

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京安贞医院 

单位级别:

三级 

Institution
hospital:

Beijing Anzhen Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京大学第一医院 

单位级别:

三甲医院 

Institution
hospital:

Peking University First Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京大学人民医院 

单位级别:

三甲医院 

Institution
hospital:

Peking University People's Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

海军总医院 

单位级别:

三甲医院 

Institution
hospital:

the naval hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

解放军301医院 

单位级别:

三甲医院 

Institution
hospital:

PLA 301 hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

解放军307医院 

单位级别:

三甲医院 

Institution
hospital:

pLA 307医院  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

空军总医 

单位级别:

三甲医院 

Institution
hospital:

the Air Force General Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京中医药大学东直门医院 

单位级别:

三甲医院 

Institution
hospital:

Beijing University of Chinese Medicine  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

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 100 years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

本研究不需随机

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

no need randomization

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

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):

NA

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

NA

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:

NA

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

NA

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2013-10-22
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