Today is 2020-11-27

The clinical characteristics and the etiology of COVID-19 infected patients with myocardial damage
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注册号:

Registration number:

ChiCTR2000039364 

最近更新日期:

Date of Last Refreshed on:

2020-10-24 

注册时间:

Date of Registration:

2020-10-24 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

心肌受损新型冠状病毒肺炎患者临床特征及损伤原因分析 

Public title:

The clinical characteristics and the etiology of COVID-19 infected patients with myocardial damage 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

心肌受损新型冠状病毒肺炎患者临床特征及损伤原因分析 

Scientific title:

The clinical characteristics and the etiology of COVID-19 infected patients with myocardial damage 

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:

汪程 

研究负责人:

朱峰,周敏 

Applicant:

Cheng Wang 

Study leader:

FengZhu, ZhouMin 

申请注册联系人电话:

Applicant telephone:

15071180920 

研究负责人电话:

Study leader's telephone:

13707145423 

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:

wangchengv@hust.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

zhufeng@hust.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:

湖北省武汉市解放大道1277号 

研究负责人通讯地址:

湖北省武汉市解放大道1095号 

Applicant address:

1277 Jiefang Avenue, Wuhan, Hubei Province 

Study leader's address:

1095 Jiefang Avenue, Wuhan, Hubei Province 

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:

华中科技大学同济医学院附属协和医院 

Applicant's institution:

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 

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:

TJ-IRB20200210 

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:

华中科技大学同济医学院附属同济医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-18 

伦理委员会联系人:

杜艾桦 

Contact Name of the ethic committee:

Aihua Du 

伦理委员会联系地址:

湖北省武汉市解放大道1095号 

Contact Address of the ethic committee:

1095 Jiefang Avenue, Wuhan, Hubei Province 

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:

华中科技大学同济医学院附属同济医院 

Primary sponsor:

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology 

研究实施负责(组长)单位地址:

湖北省武汉市解放大道1095号 

Primary sponsor's address:

1095 Jiefang Avenue, Wuhan, Hubei Province 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

湖北

市(区县):

Country:

China

Province:

Hubei

City:

单位(医院):

华中科技大学同济医学院附属同济医院

具体地址:

湖北省武汉市解放大道1095号

Institution
hospital:

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Address:

1095 Jiefang Avenue, Wuhan, Hubei Province

经费或物资来源:

华中科技大学COVID-19快速响应基金 

Source(s) of funding:

Huazhong University of Science and Technology COVID-19 Rapid Response Call 

研究疾病:

新型冠状病毒肺炎 

Target disease:

COVID-19 

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:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

明确心肌受损患者新型冠状病毒肺炎的重症率和死亡率,分析其临床特征,探讨可能的病因及导致死亡的高危因素。 

Objectives of Study:

To clarify the severe rate and death rate of COVID-19 patients with myocardial damage, analyze its clinical characteristics, and explore possible causes and high-risk factors leading to death. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

病例对照研究 

Study design:

Case-Control study 

纳入标准:

1.通过核酸诊断为新型冠状病毒感染患者 2.血液中超敏肌钙蛋白(hsTnI)超过正常上限 

Inclusion criteria

1. Diagnosis of patients with COVID-19 through nucleic acid test 2. The hypersensitivity troponin (hsTnI) in the blood exceeds the upper limit of normal 

排除标准:

1.其他病原体感染导致的肺炎; 2.未检测超敏肌钙蛋白(hsTnI)的患者。 3.不愿意参加本项临床研究者 

Exclusion criteria:

1.Pneumonia caused by infection of other pathogens; 2.Patients who have not been tested for high-sensitivity troponin (hsTnI). 3.Those who are not willing to participate in this clinical research 

研究实施时间:

Study execute time:

From2020-10-30To 2020-11-30 

征募观察对象时间:

Recruiting time:

From2020-10-30To 2020-11-30 

干预措施:

Interventions:

组别:

Case series

样本量:

200

Group:

Case series

Sample size:

干预措施:

干预措施代码:

Intervention:

non

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

华中科技大学同济医学院附属同济医院 

单位级别:

三甲医院 

Institution
hospital:

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology  

Level of the institution:

First-class hospital 

测量指标:

Outcomes:

指标中文名:

超敏肌钙蛋白I

指标类型:

主要指标 

Outcome:

high-sensitivity troponin I

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

死亡

指标类型:

主要指标 

Outcome:

death

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心电图

指标类型:

主要指标 

Outcome:

ECG

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心脏超声

指标类型:

主要指标 

Outcome:

Echocardiography

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺部CT

指标类型:

主要指标 

Outcome:

chest CT

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:

尚未开始

Not yet 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):

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

N/A

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):

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):

2021-06-30,联系通讯作者索取

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

2021-06-30, contact the corresponding author to obtain

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:

 2020-10-24
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