今天是:2019-07-21 星期日

心脏磁共振成像临床应用注册研究
下载XML文档

注册号:

Registration number:

ChiCTR1900024094 

最近更新日期:

Date of Last Refreshed on:

2019-06-25 

注册时间:

Date of Registration:

2019-06-25 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

心脏磁共振成像临床应用注册研究 

Public title:

Cardiac Magnetic Resonance Imaging Clinical Application Registration Study 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

心脏磁共振成像临床应用注册研究 

Scientific title:

Cardiac Magnetic Resonance Imaging Clinical Application Registration Study 

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:

伍琴琴 

研究负责人:

陈玉成 

Applicant:

Wu Qinqin 

Study leader:

Chen Yucheng 

申请注册联系人电话:

Applicant telephone:

+86 18381677135 

研究负责人电话:

Study leader's telephone:

+86 18980602149 

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:

qq1354554288@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

chenyucheng2003@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:

四川省成都市国学巷37号 

研究负责人通讯地址:

四川省成都市国学巷37号 

Applicant address:

37 Guoxue Lane, Chengdu, Sichuan, China 

Study leader's address:

37 Guoxue Lane, Chengdu, Sichuan, 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:

四川大学华西医院 

Applicant's institution:

West China Hospital, Sichuan 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:

2016年审(355)号 

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:

四川大学华西医院生物医学伦理分委会 

Name of the ethic committee:

Sub-Committee on Biomedical Ethics of West China Hospital, Sichuan University 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

李娜 

Contact Name of the ethic committee:

Li Na 

伦理委员会联系地址:

四川省成都市武侯区人民南路三段16号第八教学楼412室  

Contact Address of the ethic committee:

Room 412, Old 8th Teaching Building, West China Hospital, Sichuan University, 37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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:

四川大学华西医院 

Primary sponsor:

West China Hospital, Sichuan University 

研究实施负责(组长)单位地址:

四川省成都市国学巷37号 

Primary sponsor's address:

37 Guoxue Lane, Chengdu, Sichuan, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

SCI论文基金 

Source(s) of funding:

SCI Paper Fund 

研究疾病:

心血管疾病 

Target disease:

Cardiovascular diseases 

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:

探索性研究/预试验 

Study phase:

研究目的:

分析评价心脏磁共振综合成像在临床心脏病患者中的临床诊断、决策、预后价值及其成分效益分析。 

Objectives of Study:

Analyze and evaluate the clinical diagnosis, decision-making, prognostic value and component benefit analysis of cardiac magnetic resonance imaging in clinical patients with heart disease. 

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:

接受临床心脏磁共振检查的患者 

Inclusion criteria

Patients undergoing clinical cardiac magnetic resonance imaging. 

排除标准:

置有心脏起搏器者。 术后体内置有大块金属植入物(如人工股骨头、胸椎矫形钢板等)者。 术后体内置有动脉瘤止血夹者。 严重心力衰竭不能平卧者。 昏迷躁动不能配合检查者。 身体内疑有金属异物者。 幽闭恐惧症者。 

Exclusion criteria:

1. Have a pacemaker; 2. Postoperative body with large metal implants (such as artificial femoral head, thoracic orthopedic plate, etc.) 3. There is an aneurysm hemostatic clip inside the postoperative body; 4. Severe heart failure can not be supine; 5. coma and inability to cooperate with the examiner; 6. Those who are suspected of having metal foreign bodies in the body; 7. claustrophobic. 

研究实施时间:

Study execute time:

From2017-01-01To 2020-12-31 

干预措施:

Interventions:

组别:

Case series

样本量:

7000

Group:

Case series

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川省 

市(区县):

成都市 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

四川大学华西医院 

单位级别:

三甲 

Institution
hospital:

West China Hospital, Sichuan University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

诊断、决策、预后价值及其成分效益分析

指标类型:

主要指标 

Outcome:

clinical diagnosis, decision-making, prognostic value and component benefit analysis

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:

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 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):

NA

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年12月31日联系项目负责人; ResMan

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

December 31, 2020. Contact the study leader; ResMan

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:

EDC

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

EDC

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-06-25
返回列表