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心脏电-机械活动时间比值对慢性心力衰竭患者发生心脏不良时间的预测价值
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注册号:

Registration number:

ChiCTR1900021470 

最近更新日期:

Date of Last Refreshed on:

2019-02-24 

注册时间:

Date of Registration:

2019-02-22 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

心脏电-机械活动时间比值对慢性心力衰竭患者发生心脏不良时间的预测价值 

Public title:

Predictive value of cardiac electro-mechanical activity time ratio for adverse cardiac events in patients with chronic heart failure 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

心脏电-机械活动时间比值对慢性心力衰竭患者发生心脏不良时间的预测价值 

Scientific title:

Predictive value of cardiac electro-mechanical activity time ratio for adverse cardiac events in patients with chronic heart failure 

研究课题代号(代码):

Study subject ID:

心血管疾病精准医学北京实验室课题(PXM2019_014226_000023 ) 

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:

张静 

研究负责人:

刘文娴 

Applicant:

Jing Zhang 

Study leader:

Wenxian Liu 

申请注册联系人电话:

Applicant telephone:

+86 13436648872 

研究负责人电话:

Study leader's telephone:

+86 18911662882 

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:

axiu-zhangjing@163.com 

研究负责人电子邮件:

Study leader's E-mail:

18911662882@163.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:

2 Anzhen Road, Chaoyang District, Beijing, China 

Study leader's address:

2 Anzhen Road, Chaoyang District, Beijing, 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:

首都医科大学附属北京安贞医院 

Applicant's institution:

Beijing AnZhen Hospital, Capital Medical 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:

2018032X 

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:

北京安贞医院医学伦理委员会 

Name of the ethic committee:

Medical ethics committee, Beijing Anzhen Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-09-25 

伦理委员会联系人:

吴朝阳 

Contact Name of the ethic committee:

Chaoyang Wu 

伦理委员会联系地址:

北京市朝阳区安贞路2号首都医科大学附属北京安贞医院  

Contact Address of the ethic committee:

Beijing Anzhen Hospital, Capital Medical University, 2 Anzhen Road, Chaoyang District, Beijing, 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:

首都医科大学附属北京安贞医院 

Primary sponsor:

Beijing 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, 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):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

首都医科大学附属北京安贞医院

具体地址:

北京市朝阳区安贞路2号

Institution
hospital:

Beijing AnZhen Hospital, Capital Medical University

Address:

2 Anzhen Road, Chaoyang District, Beijing, China

经费或物资来源:

心血管疾病精准医学北京实验室课题(PXM2019_014226_000023 ) 

Source(s) of funding:

Beijing Lab for Cardiovascular Precision Medicine, Beijing, China (PXM2019_014226_000023) 

研究疾病:

慢性心力衰竭 

Target disease:

chronic heart disease 

研究疾病代码:

 

Target disease code:

 

研究类型:

病因学/相关因素研究 

Study type:

Cause/Relative factors study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

心脏电一机械活动时间(EMAT)为现代心音图评价左心室功能的指标之一。EMAT比值(EMAT/RR)表示EMAT在心动周期中的比例,反映左心室收缩产生足够压力关闭二尖瓣所需要的时间。该指标升高与患者左室射血分数下降相关。本研究探讨EMAT%对慢性心力衰竭患者发生院内及院外心脏不良事件的预测价值。 

Objectives of Study:

Electromechanical activation time (EMAT) is one of the parameters which evaluates left ventricular function by modern acoustic cardiography.EMATc (EMAT/RRint), which indicates the proportion of EMAT in the cardiac cycle. EMAT (EMATc) reflects the time required by left ventricular systole to produce sufficient pressure to close the mitral valve.increased EMAT (EMATc) is associated with a decline in left ventricular systolic function.The objective of this study was to analyze the predictive value of EMATc for adverse cardiac events occurring in patients with chronic heart failure. 

药物成份或治疗方案详述:

纳入2019-2-28至2020-2-28于我院住院治疗的慢性心里衰竭并满足纳入标准及排除标准的患者,记录患者入院首个24小时内EMAT%及其他临床资料。观察并记录患者住院期间及出院随访期间有无发生心脏不良事件(院内不良事件:急性左心衰加重并需要无创或有创呼吸机辅助支持、心源性休克、心源性死亡;院外不良事件:因心衰再住院、全因死亡、心源性死亡) 

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年龄>18周岁; ②LVEF<50%; ③纽约心脏病协会心功能分级Ⅲ-Ⅳ级。 

Inclusion criteria

1. age>18 years old; 2. left ventricular ejection fraction <50%; 3. NYHA classification III or IV. 

排除标准:

①急性心肌梗死的患者; ②急性心肌炎及结构性心脏病的患者; ③慢性阻塞性肺疾病急性发作的患者; ④有行冠状动脉介入、心脏外科手术计划的患者。 

Exclusion criteria:

1. acute myocardial infarction; 2. acute myocarditis, structural heart disease; 3. acute episodes of chronic obstructive pulmonary disease; 4. plans for coronary intervention or cardiac surgery during this hospitalization 

研究实施时间:

Study execute time:

From2019-02-28To 2020-02-28 

征募观察对象时间:

Recruiting time:

From2019-02-28To 2020-02-28 

干预措施:

Interventions:

组别:

心脏不良事件组和无心脏不良事件组

样本量:

140

Group:

Group with and without cardiac adverse events

Sample size:

干预措施:

观察性无干预

干预措施代码:

Intervention:

NO intervention

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):

首都医科大学附属北京安贞医院 

单位级别:

三甲综合性医院 

Institution
hospital:

Beijing AnZhen Hospital, Capital Medical University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

心脏电-机械活动时间比值

指标类型:

主要指标 

Outcome:

Cardiac electro-mechanical activation time ratio

Type:

Primary indicator 

测量时间点:

入院后24小时内

测量方法:

Measure time point of outcome:

in the first 24 hours after admission

Measure method:

指标中文名:

B型脑钠肽

指标类型:

次要指标 

Outcome:

type B natriuretic peptide

Type:

Secondary indicator 

测量时间点:

入院24小时内

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

左室射血分数

指标类型:

次要指标 

Outcome:

left ventricular ejection fraction

Type:

Secondary indicator 

测量时间点:

测量方法:

超声心动图

Measure time point of outcome:

Measure method:

指标中文名:

肌钙蛋白I

指标类型:

次要指标 

Outcome:

tropnin I

Type:

Secondary indicator 

测量时间点:

入院24小时内

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 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):

前瞻观察性研究,未进行干预和随机分组

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

N/A

盲法:

N/A

Blinding:

N/A

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):

2020-8-28发表论文后公开

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

2020-8-28 Published, after publication,

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:

病例记录表

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

Case record form;CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-02-22
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