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: |
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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: |
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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: |
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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): |
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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: |
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申请人所在单位: |
北京市安贞医院 |
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Applicant's institution: |
Beijing Anzhen hospital |
是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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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: |
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批准本研究的伦理委员会名称: |
北京安贞医院伦理委员会 |
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Name of the ethic committee: |
Beijin Anzhen Hospital ethics committee |
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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: |
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Contact Name of the ethic committee: |
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伦理委员会联系地址: |
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Contact Address of the ethic committee: |
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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: |
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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: |
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Target disease code: |
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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: |
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Description for medicine or protocol of treatment in detail: |
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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: |
从From2011-06-10至To 2013-12-31 |
征募观察对象时间: Recruiting time: |
从From2011-06-10至To 2013-12-31 |
干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
正在进行 Recruiting |
年龄范围: Participant age: |
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性别: |
男性 |
Gender: |
Male |
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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 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
no need randomization |
盲法: |
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Blinding: |
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试验完成后的统计结果(上传文件): |
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Calculated Results after
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是否共享原始数据: IPD sharing |
否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 |