图注意力网络对比传统聚类在缺血性卒中患者亚组识别中的效能优势及预后泛化能力研究

注册号:

Registration number:

ChiCTR2500113279 

最近更新日期:

Date of Last Refreshed on:

2025-11-26 17:26:04 

注册时间:

Date of Registration:

2025-11-26 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

图注意力网络对比传统聚类在缺血性卒中患者亚组识别中的效能优势及预后泛化能力研究

Public title:

Using Graph Attention Network to Identify High-Risk Subgroups and Predict Prognosis in Ischemic Stroke Patients

注册题目简写:

English Acronym:

研究课题的正式科学名称:

图注意力网络对比传统聚类在缺血性卒中患者亚组识别中的效能优势及预后泛化能力研究

Scientific title:

Using Graph Attention Network to Identify High-Risk Subgroups and Predict Prognosis in Ischemic Stroke Patients

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:

李川雄 

研究负责人:

李川雄 

Applicant:

Chuanxiong Li 

Study leader:

Chuanxiong Li 

申请注册联系人电话:

Applicant telephone:

+86 183 1387 1217

研究负责人电话:

Study leader's
telephone:

+86 183 1387 1217

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:

352784777@qq.com

研究负责人电子邮件:

Study leader's E-mail:

352784777@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:

云南省,昆明市,五华区,青年路176号

研究负责人通讯地址:

云南省,昆明市,五华区,青年路176号

Applicant address:

176, Qingnian Road, Wuhua District, Kunming City, Yunnan Province, China

Study leader's address:

176, Qingnian Road, Wuhua District, Kunming City, Yunnan Province, China

申请注册联系人邮政编码:

Applicant postcode:

650000

研究负责人邮政编码:

Study leader's postcode:

650000

申请人所在单位:

云南大学附属医院

Applicant's institution:

The Affiliated Hospital of Yunnan University

研究负责人所在单位:

云南大学附属医院

Affiliation of the Leader:

The Affiliated Hospital of Yunnan University

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:

The Affiliated Hospital of Yunnan University

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:

云南大学附属医院伦理委员会

Name of the ethic committee:

Ethics Committee of the Affiliated Hospital of Yunnan University

伦理委员会批准日期:

Date of approved by ethic committee:

2025-11-11 00:00:00

伦理委员会联系人:

陈麟

Contact Name of the ethic committee:

Lin Chen

伦理委员会联系地址:

云南省,昆明市,五华区,青年路176号

Contact Address of the ethic committee:

176, Qingnian Road, Wuhua District, Kunming City, Yunnan Province, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 153 6817 7822

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:

云南大学附属医院

Primary sponsor:

The Affiliated Hospital of Yunnan University

研究实施负责(组长)单位地址:

云南省,昆明市,五华区,青年路176号

Primary sponsor's address:

176, Qingnian Road, Wuhua District, Kunming City, Yunnan 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):

云南省

市(区县):

昆明市

Country:

China

Province:

Yunnan

City:

Kunming

单位(医院):

云南大学附属医院

具体地址:

云南省,昆明市,五华区,青年路176号

Institution
hospital:

The Affiliated Hospital of Yunnan University

Address:

176, Qingnian Road, Wuhua District, Kunming City, Yunnan Province, China

经费或物资来源:

自筹

Source(s) of funding:

Self-funded

研究疾病:

缺血性脑卒中  

Target disease:

Ischemic Stroke

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:

横断面 

Study design:

Cross-sectional 

研究目的:

研究旨在通过图注意力网络(GAT)对缺血性脑卒中患者进行高危亚组识别,并验证其在临床预后中的应用,进一步提升精准分层干预策略的效果。  

Objectives of Study:

This study aims to identify high-risk subgroups of ischemic stroke patients using Graph Attention Networks (GAT) and validate its application in clinical prognosis to enhance the effectiveness of precision stratified interventions.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

Inclusion criteria

排除标准:

1.入院和/或出院临床资料不完整的患者 2.非脑血管疾病导致的意识障碍 3.缺失康复功能评定数据 4.在住院期间不能进行相关康复功能锻炼的患者

Exclusion criteria:

1. Patients with incomplete clinical records at admission and/or discharge 2. Impaired consciousness not attributable to cerebrovascular disease 3. Missing rehabilitation functional assessment data 4. Patients unable to undertake relevant rehabilitation exercises during hospitalisation

研究实施时间:

Study execute time:

From 2025-12-01 00:00:00 To 2026-12-01 00:00:00  

征募观察对象时间:

Recruiting time:

From 2025-12-01 00:00:00 To 2026-06-30 00:00:00

干预措施:

Interventions:

组别:

病例组

样本量:

500

Group:

Case group

Sample size:

干预措施:

干预措施代码:

Intervention:

NA

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

云南省 

市(区县):

昆明市 

Country:

China

Province:

Yunnan

City:

Kunming

单位(医院):

云南大学附属医院 

单位级别:

三甲 

Institution
hospital:

The Affiliated Hospital of Yunnan University

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

功能恢复(ADL 评分)

指标类型:

主要指标

Outcome:

Functional recovery (ADL score)

Type:

Primary indicator

测量时间点:

出院时和康复随访时

测量方法:

Measure time point of outcome:

At discharge and during rehabilitation follow-up

Measure method:

指标中文名:

死亡率

指标类型:

主要指标

Outcome:

Mortality Rate

Type:

Primary indicator

测量时间点:

出院后1个月、3个月和6个月

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

临床生理参数(SOFA评分)

指标类型:

次要指标

Outcome:

Clinical Physiological Parameters (SOFA Score)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

认知功能(包括MMSE、Moca评分)

指标类型:

次要指标

Outcome:

Cognitive Function (MMSE, MoCA Score)

Type:

Secondary 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

指标类型:

次要指标

Outcome:

Quality of Life

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

神经功能评分(包括Brunnstrom分期、改良Ashworth评分)

指标类型:

次要指标

Outcome:

Neurological Function Score (Brunnstrom Stage, Modified Ashworth Score)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

并发症发生率

指标类型:

次要指标

Outcome:

Incidence of Complications

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生存质量(VAS评分、疼痛评估)

指标类型:

次要指标

Outcome:

Quality of Life (VAS Score, Pain Assessment)

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:

NA

Tissue:

NA

人体标本去向

使用后销毁  

说明

Fate of sample:

Destruction after use  

Note:

NA

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 18 years
最大 Max age 80 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):

本研究为观察性研究,未涉及随机化过程

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

This is an observational study with no randomization involved

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

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):

将在研究结束后,通过医院的临床数据库进行共享,并提供相关的元数据和协议

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

The data will be shared via the hospital’s clinical database after the study is completed, including metadata and protocols

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:

本研究采用Case Record Form (CRF)收集临床数据,所有数据将通过电子数据捕捉系统(EDC)进行管理和存储,如使用RedCap等平台

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

This study collects clinical data using Case Record Forms (CRF), and all data will be managed and stored through an Electronic Data Capture (EDC) system, such as RedCap

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:

 2025-11-26 17:25:59