今天是:2022-08-12 星期五

高龄冠状动脉旁路移植术患者身体质量指数变化特征与近远期预后的观察性研究
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注册号:

Registration number:

ChiCTR2200061869 

最近更新日期:

Date of Last Refreshed on:

2022-07-05 

注册时间:

Date of Registration:

2022-07-05 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

高龄冠状动脉旁路移植术患者身体质量指数变化特征与近远期预后的观察性研究 

Public title:

Observational study of body mass index changes and short - and long-term prognosis in elderly patients undergoing coronary artery bypass grafting  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

高龄冠状动脉旁路移植术患者身体质量指数变化特征与近远期预后的观察性研究 

Scientific title:

Observational study of body mass index changes and short - and long-term prognosis in elderly patients undergoing coronary artery bypass grafting  

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:

张杨杨 

研究负责人:

张杨杨 

Applicant:

Zhang Yangyang 

Study leader:

Zhang Yangyang 

申请注册联系人电话:

Applicant telephone:

13818132320 

研究负责人电话:

Study leader's telephone:

13818132320 

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:

lmw758995787@163.com 

研究负责人电子邮件:

Study leader's E-mail:

zhangyangyang_wy@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):

 

申请注册联系人通讯地址:

上海市淮海西路241号 

研究负责人通讯地址:

上海市淮海西路241号 

Applicant address:

241 Huaihai West Road, Shanghai 

Study leader's address:

241 Huaihai West Road, Shanghai 

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:

上海交通大学附属胸科医院 

Applicant's institution:

Chest Hospital affiliated to Shanghai Jiaotong 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:

IS22036 

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:

上海市胸科医院伦理委员会 

Name of the ethic committee:

Ethics Committee of the Shanghai Chest Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

郑宁 

Contact Name of the ethic committee:

Zheng Ning 

伦理委员会联系地址:

上海市淮海西路241号 

Contact Address of the ethic committee:

241 Huaihai West Road, Shanghai 

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:

上海交通大学附属胸科医院 

Primary sponsor:

Chest Hospital affiliated to Shanghai Jiaotong University 

研究实施负责(组长)单位地址:

上海交通大学附属胸科医院 

Primary sponsor's address:

Chest Hospital affiliated to Shanghai Jiaotong University 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海市

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海交通大学附属胸科医院

具体地址:

上海市淮海西路241号

Institution
hospital:

Chest Hospital affiliated to Shanghai Jiaotong University

Address:

241 Huaihai West Road, Shanghai

经费或物资来源:

自发 

Source(s) of funding:

spontaneous 

研究疾病:

CABG术后与BMI 

Target disease:

CABG and BMI 

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:

老年心脏手术患者常伴有多种代谢共病,如糖尿病(DM)、肥胖等。这些个体的代谢紊乱被广泛认为是不良预后的可能易感性因素。本回顾性研究旨在确定代谢性疾病与老年患者冠状动脉搭桥术(CABG)后死亡率的关系,并确定与他们的短期和长期生存相关的保护性或危险因素。 

Objectives of Study:

Elderly patients undergoing cardiac operation often suffer various metabolic comorbidities, such as diabetes mellitus (DM) and obesity. The metabolic disorders in these individuals are widely considered to be possible predisposing factors for unfavourable prognosis. This retrospective study is aimed to determine the association of metabolic diseases with the mortality of elderly patients after coronary artery bypass grafting (CABG) and to identify the protective or risk factors related to their short- and long-term survival. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

本回顾性研究以江苏省医院(JSPH)he 上海市胸科医院(SHCH)行冠脉搭桥的患者为研究对象。 

Inclusion criteria

This retrospective cohort study involved patients undergoing CABG from either Jiangsu Province Hospital (JSPH) and Shanghai Chest Hospital (SHCH).  

排除标准:

1)年龄<75岁;2)二次冠脉搭桥;3)严重无病历记录。 

Exclusion criteria:

1) age<75 years old, 2) redo CABG, and 3) severe absence of medical records.  

研究实施时间:

Study execute time:

From2022-06-20To 2022-07-20 

征募观察对象时间:

Recruiting time:

From2022-06-21To 2022-07-19 

干预措施:

Interventions:

组别:

1

样本量:

684

Group:

1

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海交通大学附属胸科医院 

单位级别:

上海市三甲医院 

Institution
hospital:

Chest Hospital affiliated to Shanghai Jiaotong University  

Level of the institution:

Shanghai Third Class A Hospital 

国家:

中国 

省(直辖市):

江苏 

市(区县):

 

Country:

China 

Province:

Jiangsu 

City:

 

单位(医院):

南京医科大学附属第一医院 

单位级别:

江苏省三甲医院 

Institution
hospital:

The First Affiliated Hospital of Nanjing Medical University  

Level of the institution:

Jiangsu Third Class A Hospital 

测量指标:

Outcomes:

指标中文名:

身体质量指数

指标类型:

主要指标 

Outcome:

Body mass index

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

院内死亡率

指标类型:

主要指标 

Outcome:

In-hospital mortality

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

长期死亡率

指标类型:

主要指标 

Outcome:

Long-term mortality

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

年龄

指标类型:

次要指标 

Outcome:

age

Type:

Secondary 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:

组织:

Sample Name:

None

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 75 years
最大 Max age 90 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:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

是Yes

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):

2022-10-30 在中国临床试验注册中心公布结果 www.chictr.org.cn

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

October-30 2022, the data will be issued on the website:www.chictr.org.cn

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:

病历记录表

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

CRF

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2022-07-05
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