ChiCTR2600119442 版本V1.0 版本创建时间2026/02/27 09:52:13 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:

ChiCTR2600119442 

最近更新日期:

Date of Last Refreshed on:

2026-02-27 09:52:09 

注册时间:

Date of Registration:

2026-02-27 00:00:00 

注册号状态:

补注册

Registration Status:

Retrospective registration

注册题目:

基于机器学习的老年慢性心力衰竭患者厌食症风险动态预测模型构建

Public title:

Construction of a Dynamic Prediction Model for Anorexia Risk in Elderly Patients with Chronic Heart Failure Based on Machine Learning

注册题目简写:

English Acronym:

研究课题的正式科学名称:

基于机器学习的老年慢性心力衰竭患者厌食症风险动态预测模型构建及精准干预策略研究

Scientific title:

Construction of a Dynamic Prediction Model for Anorexia Risk in Elderly Patients with Chronic Heart Failure Based on Machine Learning and Research on Precision Intervention Strategies

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:

张波 

研究负责人:

张波 

Applicant:

Zhang Bo 

Study leader:

Zhang Bo 

申请注册联系人电话:

Applicant telephone:

+86 138 8059 1650

研究负责人电话:

Study leader's telephone:

+86 138 8059 1650

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:

919942183@qq.com

研究负责人电子邮件:

Study leader's E-mail:

919942813@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:

中国四川省成都市郫都区德源北路666号

研究负责人通讯地址:

中国四川省成都市郫都区德源北路666号

Applicant address:

666 Deyuan North Road, Pidu District, Chengdu City, Sichuan Province, China

Study leader's address:

666 Deyuan North Road, Pidu District, Chengdu City, Sichuan Province, 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:

成都医科大学第三附属医院.四川省成都市郫都区人民医院

Applicant's institution:

The Third Affiliated Hospital of Chengdu Medical University People's Hospital of Pidu District, Chengdu City, Sichuan Province

研究负责人所在单位:

成都医科大学第三附属医院.四川省成都市郫都区人民医院

Affiliation of the Leader:

The Third Affiliated Hospital of Chengdu Medical University People's Hospital of Pidu District, Chengdu City, Sichuan Province

是否获伦理委员会批准:

是/Yes

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

伦委批字[2025]第67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:

成都市郫都区人民医院医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee of Chengdu Pidu District People's Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2025-08-08 00:00:00

伦理委员会联系人:

吴攀

Contact Name of the ethic committee:

Wu Pan

伦理委员会联系地址:

中国四川省成都市郫都区德源北路二段666号

Contact Address of the ethic committee:

666 Second Section, De Yuan North Road, Weidu District, Chengdu City, Sichuan Province, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 186 8137 2836

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:

成都医科大学第三附属医院.四川省成都市郫都区人民医院

Primary sponsor:

The Third Affiliated Hospital of Chengdu Medical University People's Hospital of Pidu District, Chengdu City, Sichuan Province

研究实施负责(组长)单位地址:

中国四川省成都市郫都区德源北路二段666号

Primary sponsor's address:

666 Second Section, De Yuan North Road, Weidu District, Chengdu City, Sichuan Province, 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):

四川

市(区县):

成都

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

成都医科大学第三附属医院.四川省成都市郫都区人民医院

具体地址:

中国四川省成都市郫都区德源北路二段666号

Institution
hospital:

The Third Affiliated Hospital of Chengdu Medical University People's Hospital of Pidu District, Chengdu City, Sichuan Province

Address:

666 Second Section, De Yuan North Road, Weidu District, Chengdu City, Sichuan Province, China

经费或物资来源:

成都医科大学第三附属医院.四川省成都市郫都区人民医院

Source(s) of funding:

The Third Affiliated Hospital of Chengdu Medical University People's Hospital of Pidu District, Chengdu City, Sichuan Province

Target disease:

Anorexia in elderly patients with chronic heart failure

Target disease code:

研究类型:

观察性研究

Study type:

Observational study

研究所处阶段:

其它 

Study phase:

N/A

研究设计:

横断面 

Study design:

Cross-sectional 

研究目的:

评估老年慢性心力衰竭患者厌食症的现状,分析相关危险因素;利用机器学习算法,确定老年慢性心力衰竭患者厌食症的动态预测模型;  

Objectives of Study:

To assess the current status of anorexia in elderly patients with chronic heart failure, analyze the related risk factors; and establish a dynamic prediction model for anorexia in this patient population by using machine learning algorithms.

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. 年龄>=60 岁; 2. 实验室检查诊断为慢性心力衰竭患者; 3. 美国纽约心脏病学会心功能分级Ⅱ级及以上; 4. 意识清醒,无精神病史,无认知功能障碍和严重躯体疾病。

Inclusion criteria

1. Age >=60 years old; 2. A patient diagnosed with chronic heart failure through laboratory tests; 3. New York College of Cardiology's cardiac function classification of grade II or above; 4. Conscious, without a history of mental illness, cognitive dysfunction or serious physical diseases.

排除标准:

1. 患者不配合者; 2. 合并严重消化系统疾病,需长期禁食者; 3. 存在严重器质性疾病或精神障碍。

Exclusion criteria:

1. Patients who do not cooperate; 2. Those with severe digestive system diseases who require long-term fasting; 3. There are severe organic diseases or mental disorders.

研究实施时间:

Study execute time:

From 2025-08-08 00:00:00 To 2027-04-01 00:00:00  

征募观察对象时间:

Recruiting time:

From 2025-08-08 00:00:00 To 2027-04-01 00:00:00  

干预措施:

Interventions:

组别:

训练集

样本量:

300

Group:

Training set

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

组别:

验证集

样本量:

150

Group:

Validation set

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):

四川 

市(区县):

成都 

Country:

China 

Province:

Sichuan 

City:

Chengdu  

单位(医院):

成都医科大学第三附属医院.成都市郫都区人民医院 

单位级别:

三甲 

Institution
hospital:

The Third Affiliated Hospital of Chengdu Medical University. Chengdu Prefecture District People's Hospital

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

厌食症发生情况(基于SNAQ评分<=14分)

指标类型:

主要指标

Outcome:

Anorexia incidence (based on SNAQ score <=14)

Type:

Primary indicator

测量时间点:

测量方法:

简化营养食欲评估表(SNAQ)

Measure time point of outcome:

Measure method:

Short Nutritional Appetite Questionnaire (SNAQ)

指标中文名:

简化营养食欲评估表(SNAQ)得分

指标类型:

主要指标

Outcome:

Short Nutritional Appetite Questionnaire (SNAQ) score

Type:

Primary indicator

测量时间点:

测量方法:

简化营养食欲评估表(SNAQ)

Measure time point of outcome:

Measure method:

Short Nutritional Appetite Questionnaire (SNAQ)

指标中文名:

营养知识和态度得分

指标类型:

主要指标

Outcome:

Nutrition knowledge and attitude score

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

饮食自我效能得分

指标类型:

主要指标

Outcome:

Dietary self-efficacy score

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

运动自我效能得分

指标类型:

主要指标

Outcome:

Exercise self-efficacy score

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活质量得分

指标类型:

主要指标

Outcome:

Quality of life score

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:

静脉血标本

Sample Name:

Blood

Tissue:

Venous blood samples

人体标本去向

使用后销毁  

说明

使用后销毁

Fate of sample:

Destruction after use  

Note:

Destruction after use

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 60 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

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):

论文发表后半年内,国家生物信息中心https://www.cncb.ac.cn/。

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

Within six months after the paper is published, the National Center for Bioinformation https://www.cncb.ac.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:

病例记录

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

Case Record

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:

 2026-02-27 09:52:09