Today is 2019-12-10

Development and External Validation of a Diagnostic Model of Bleeding in Patient Hospitalized with Acute ST-Elevation Myocardial Infarction
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注册号:

Registration number:

ChiCTR1900027578 

最近更新日期:

Date of Last Refreshed on:

2019-11-19 

注册时间:

Date of Registration:

2019-11-19 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

急性ST段抬高型心肌梗死住院出血诊断模型的建立和外部验证 

Public title:

Development and External Validation of a Diagnostic Model of Bleeding in Patient Hospitalized with Acute ST-Elevation Myocardial Infarction  

注册题目简写:

出血诊断模型的建立和外部验证 

English Acronym:

Development and External Validation of a Diagnostic Model of Bleeding  

研究课题的正式科学名称:

急性ST段抬高型心肌梗死住院出血诊断模型的建立和外部验证 

Scientific title:

Development and External Validation of a Diagnostic Model of Bleeding in Patient Hospitalized with Acute ST-Elevation Myocardial Infarction  

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:

李勇 

研究负责人:

李勇 

Applicant:

Yong Li 

Study leader:

Yong Li 

申请注册联系人电话:

Applicant telephone:

+86 13910227262 

研究负责人电话:

Study leader's telephone:

+86 13910227262 

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:

liyongdoctor@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

liyongdoctor@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:

北京市西城区马甸南村5号楼405 

研究负责人通讯地址:

北京市西城区马甸南村5号楼405 

Applicant address:

Room 405, Building 5, Madian South Village, Xicheng District, Beijing, China  

Study leader's address:

Room 405, Building 5, Madian South Village, Xicheng District, Beijing, China Room 405, Building 5, Madian South Village, Xicheng District, Beijing, China  

申请注册联系人邮政编码:

Applicant postcode:

1000029 

研究负责人邮政编码:

Study leader's postcode:

1000029 

申请人所在单位:

首都医科大学附属北京安贞医院急诊危重症中心  

Applicant's institution:

Emergency and Critical Care Center, 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:

2019044X 

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:

首都医科大学附属北京安贞医院医学伦理委员会  

Name of the ethic committee:

Ethics Committee of Beijing Anzhen Hospital, Capital Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-11-18 

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:

中国北京朝阳区安贞路2号 

Contact Address of the ethic committee:

2 Anzhen Road, Chaoyang, Beijing, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 010-64456214 

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急诊危重症中心  

Primary sponsor:

Emergency and Critical Care Center, Beijing Anzhen Hospital, Capital Medical University  

研究实施负责(组长)单位地址:

首都医科大学附属北京安贞医院 北京朝阳区安贞路2号 

Primary sponsor's address:

2 Anzhen Road, Chaoyang, 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

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:

朝阳区安贞路2号

Institution
hospital:

Beijing Anzhen Hospital, Capital Medical University

Address:

2 Anzhen Road, Chaoyang District

经费或物资来源:

自筹资金 

Source(s) of funding:

Self-funding 

研究疾病:

ST段抬高型心肌梗死 

Target disease:

ST- elevation myocardial infarction  

研究疾病代码:

 

Target disease code:

 

研究类型:

诊断试验 

Study type:

Diagnostic test 

研究所处阶段:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

建立和外部验证急性ST段抬高型心肌梗死住院出血诊断模型。 

Objectives of Study:

We want to develop and externally validate a diagnostic model of in-hospital bleeding in patients with acute STEMI.  

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.急性STEMI患者; 2.年龄超过18岁。当急性心肌损伤伴有急性心肌缺血的临床证据并且检测到cTnI值的上升和/或下降至少有一个值高于第99百分位数上限时,并且至少有下列之一: (1)心肌缺血的症状; (2)新的缺血性心电图改变可诊断急性心肌梗死(AMI)。STEMI的诊断是指存在与心电图改变(至少2个肢体心电图导联ST段抬高> 1 mm或至少2个连续心前区> 2 mm )相关的持续> 20分钟的胸痛。  

Inclusion criteria

1. Patients with acute STEMI; 2. Aged more than 18 years. The term acute myocardial infarction (AMI) should be used when there is acute myocardial injury with clinical evidence of acute myocardial ischemia and with detection of a rise and/or fall of cTnI values with at least one value above the 99th percentile upper reference limit and at least one of the following: (1) Symptoms of myocardial ischaemia; (2) New ischemic ECG changes. [1]We established the diagnosis of STEMI in the presence of chest pain lasting for >20 minutes associated with electrocardiographic changes (ST-segment elevation of > 1 mm in at least 2 extremity electrocardiographic leads or > 2 mm in at least 2 contiguous precordial leads).  

排除标准:

无 

Exclusion criteria:

None 

研究实施时间:

Study execute time:

From2019-11-26To 2020-11-25 

诊断措施:

Diagnostic measures:

金标准或参考标准(即可准确诊断某疾病的单项方法或多项联合方法,在本研究中用于诊断是否有该病的临床参考标准):

临床结局

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

Clinical outcome

指标试验(即本研究的待评估诊断试验,无论为方法、生物标志物或设备,均请列出名称):

急性ST段抬高型心肌梗死住院出血诊断模型

Index test:

A diagnostic model of in-hospital bleeding in patients with acute STEMI.

目标人群(可以是某种疾病患者或正常人群,详细描述其疾病特征,注意应纳入符合分布特点的全序列病例,具有良好的代表性)

急性STEMI患者

例数:

Sample size:

9668

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

Acute STEMI patients

容易混淆的疾病人群(即与目标疾病不易区分的一种或多种不同疾病,应避免采用正常人群对照的病例-对照设计):

例数:

Sample size:

0

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京市 

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:

三级甲等 

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:

住院出血

指标类型:

主要指标 

Outcome:

in-hospital bleeding

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 91 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):

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

None

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

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):

2021年5月

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

May 2021

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:

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

None

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-11-19
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