ChiCTR2600120603 版本V1.0 版本创建时间2026/03/17 11:47:25 中国临床试验注册中心

审核状态:

Project audit state:

通过审核

Successful

注册号:

Registration number:

ChiCTR2600120603 

最近更新日期:

Date of Last Refreshed on:

2026-03-17 11:47:18 

注册时间:

Date of Registration:

2026-03-17 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

高龄老年人群心肾代谢异常对预后的影响

Public title:

Impact of Cardio-Renal-Metabolic Abnormalities on Prognosis in Older Adults

注册题目简写:

English Acronym:

研究课题的正式科学名称:

高龄老年人群心肾代谢异常对预后的影响

Scientific title:

Impact of Cardio-Renal-Metabolic Abnormalities on Prognosis in Older Adults

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:

王艺凡 

研究负责人:

曹丰 

Applicant:

Wang Yifan 

Study leader:

Cao Feng 

申请注册联系人电话:

Applicant telephone:

+86 136 3085 1810

研究负责人电话:

Study leader's
telephone:

+86 139 1179 8280

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:

1209748788@qq.com

研究负责人电子邮件:

Study leader's E-mail:

1209748788@qq.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:

北京市海淀区复兴路28号

研究负责人通讯地址:

北京市海淀区复兴路28号

Applicant address:

No. 28, Fuxing Road, Haidian District, Beijing

Study leader's address:

No. 28, Fuxing Road, Haidian District, Beijing

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:

中国人民解放军总医院

Applicant's institution:

Chinese PLA General Hospital

研究负责人所在单位:

中国人民解放军总医院

Affiliation of the Leader:

Chinese PLA General Hospital

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

S2026-013-01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:

中国人民解放军总医院医学伦理委员会

Name of the ethic committee:

Ethics Committee of Chinese PLA General Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2026-01-12 00:00:00

伦理委员会联系人:

周听语

Contact Name of the ethic committee:

Zhou Tingyu

伦理委员会联系地址:

北京市海淀区复兴路28号

Contact Address of the ethic committee:

No. 28, Fuxing Road, Haidian District, Beijing

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 185 3125 1103

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:

中国人民解放军总医院

Primary sponsor:

Chinese PLA General Hospital

研究实施负责(组长)单位地址:

北京市海淀区复兴路28号

Primary sponsor's address:

No. 28, Fuxing Road, Haidian District, Beijing

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):

解放军总医院

具体地址:

北京市海淀区复兴路28号

Institution
hospital:

People's Liberation Army General Hospital

Address:

No. 28, Fuxing Road, Haidian District, Beijing

经费或物资来源:

研究者自发课题

Source(s) of funding:

Researcher-initiated project

研究疾病:

心血管疾病  

Target disease:

cardiovascular disease

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

研究设计:

队列研究 

Study design:

Cohort study 

研究目的:

分析高龄老年人群心肾代谢异常的临床特征,识别共病危险因素,并探讨该共病人群发生主要不良心血管事件(MACE)的影响因素。  

Objectives of Study:

Analyze the clinical characteristics of cardiovascular and renal metabolic abnormalities in the elderly population, identify risk factors for comorbidities, and explore the factors influencing the occurrence of major adverse cardiovascular events (MACE) in this comorbid population.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

1.≥80 岁的患者; 2.病例信息完整

Inclusion criteria

1. Patients aged ≥80 years; 2. Complete case information.

排除标准:

1.恶性肿瘤终末期; 2.临床资料不完整

Exclusion criteria:

1. Terminal stage of malignant tumor 2. Incomplete clinical data.

研究实施时间:

Study execute time:

From 2025-01-01 00:00:00 To 2027-06-30 00:00:00  

征募观察对象时间:

Recruiting time:

From 2026-03-17 00:00:00 To 2027-06-30 00:00:00

干预措施:

Interventions:

组别:

观察组

样本量:

2000

Group:

Observation group

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):

北京 

市(区县):

 

Country:

China

Province:

Beijing

City:

单位(医院):

中国人民解放军总医院 

单位级别:

三甲 

Institution
hospital:

Chinese PLA General Hospital

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

高密度脂蛋白亚组分

指标类型:

主要指标

Outcome:

High-density lipoprotein subfractions

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

主要不良心血管事件(MACE)

指标类型:

主要指标

Outcome:

major adverse cardiovascular events (MACE)

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

使用后保存  

说明

Fate of sample:

Preservation 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 80 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):

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

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

否No

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):

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

None

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

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2026-03-17 11:47:18