Influenceof blood pressure variability and dyslipidemiaonprognosis in young and middle-aged patients with ischemic stroke

注册号:

Registration number:

ChiCTR2600119108 

最近更新日期:

Date of Last Refreshed on:

2026-02-23 17:55:44 

注册时间:

Date of Registration:

2026-02-23 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

中青年缺血性脑卒中患者血压变异性和血脂异常对预后的影响

Public title:

Influenceof blood pressure variability and dyslipidemiaonprognosis in young and middle-aged patients with ischemic stroke

注册题目简写:

English Acronym:

研究课题的正式科学名称:

中青年缺血性脑卒中患者血压变异性和血脂异常对预后的影响

Scientific title:

Influenceof blood pressure variability and dyslipidemiaonprognosis in young and middle-aged patients with ischemic stroke

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:

李敏 

研究负责人:

李敏 

Applicant:

Li Min 

Study leader:

Li Min 

申请注册联系人电话:

Applicant telephone:

+86 10 89999013

研究负责人电话:

Study leader's telephone:

+86 10 89999015

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:

lmxbb@126.com

研究负责人电子邮件:

Study leader's E-mail:

lmxbb@126.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:

北京市平谷区新平北路59号

研究负责人通讯地址:

北京市平谷区新平北路59号

Applicant address:

No. 59, Xinping North Road, Pinggu District, Beijing

Study leader's address:

No. 59, Xinping North Road, Pinggu 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:

北京市平谷区医院

Applicant's institution:

Beijing Pinggu Hospital

研究负责人所在单位:

北京市平谷区医院

Affiliation of the Leader:

Beijing Pinggu Hospital

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:

2026-科006-01

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:

北京市平谷区医院医学伦理委员会

Name of the ethic committee:

Beijing pinggu Hospital Medical Ethics Committee

伦理委员会批准日期:

Date of approved by ethic committee:

2026-02-11 00:00:00

伦理委员会联系人:

赵翠伶

Contact Name of the ethic committee:

Zhao Cuiling

伦理委员会联系地址:

北京市平谷区新平北路59号

Contact Address of the ethic committee:

No. 59, Xinping North Road, Pinggu District, Beijing

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 10 89978829

伦理委员会联系人邮箱:

Contact email of the ethic committee:

13693052773@163.com

研究实施负责(组长)单位:

北京市平谷区医院

Primary sponsor:

Beijing Friendship Hospital Pinggu Campus,Capital Medical University

研究实施负责(组长)单位地址:

北京市平谷区新平北路59号

Primary sponsor's address:

No. 59, Xinping North Road, Pinggu 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):

北京市平谷区医院

具体地址:

北京市平谷区新平北路59号

Institution
hospital:

Beijing Friendship Hospital Pinggu Campus,Capital Medical University

Address:

No. 59, Xinping North Road, Pinggu District, Beijing

经费或物资来源:

自选课题(自筹)

Source(s) of funding:

Self-selected topic (self-funded)

Target disease:

Young and middle-aged patients with ischemic stroke

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:

了解中青年缺血性脑卒中患者血压变异性及血脂异常现状,并探讨其与预后的关系。  

Objectives of Study:

To understand the current status of blood pressure variability and dyslipidemia in young and middle-aged patients with ischemic stroke, and to explore their relationship with prognosis.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

1.18岁~60岁的中青年患者; 2.符合缺血性脑卒中诊断标准,并经头部影像学检查证实; 3.按要求完成研究所需的各项检查; 4.患者从发病到入院接受治疗的时间在72h之内

Inclusion criteria

1. Middle-aged and young patients aged 18 to 60; 2. Meeting the diagnostic criteria for ischemic stroke and confirmed by head imaging examination; 3. Completing all the required tests as per the study requirements; 4. The time from the onset of the disease to admission for treatment was within 72 hours.

排除标准:

1.非缺血性卒中;
2.合并严重心、肝、肾功能不全等严重疾病;
3.近期(入院前3个月内)使用过可能严重影响血压或血脂代谢的药物(免疫抑制剂等);
4.合并严重痴呆、精神疾病或其他原因无法配合完成血压监测及预后评估者;
5.心源性脑栓塞患者;
6.数据不全或缺失;

Exclusion criteria:

1.Non-ischemic stroke;
2.Comorbid with severe systemic diseases (e.g., severe cardiac, hepatic, or renal dysfunction);
3.Recent use (within 3 months prior to admission) of medications that may significantly affect blood pressure or lipid metabolism (e.g., immunosuppressants);
4.Comorbid with severe dementia, psychiatric disorders, or other conditions rendering the patient unable to cooperate with blood pressure monitoring and prognostic evaluation;
5.Patients with cardiogenic cerebral embolism;
6.Incomplete or missing data;

研究实施时间:

Study execute time:

From 2026-02-01 00:00:00 To 2026-05-30 00:00:00  

征募观察对象时间:

Recruiting time:

From 2026-02-23 00:00:00 To 2026-05-30 00:00:00  

干预措施:

Interventions:

组别:

预后不良组

样本量:

106

Group:

Favorable prognosis group

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

组别:

预后良好组

样本量:

206

Group:

Favorable prognosis 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 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京市平谷区医院 

单位级别:

三级 

Institution
hospital:

Beijing Friendship Hospital Pinggu Campus,Capital Medical University

Level of the institution:

Tertiary

测量指标:

Outcomes:

指标中文名:

血压变异性

指标类型:

次要指标

Outcome:

Blood pressure variability

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

出院后6个月mRs评分

指标类型:

主要指标

Outcome:

6-month mRs score after discharge

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血脂检测

指标类型:

次要指标

Outcome:

Blood lipid test

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

其它  

说明

Fate of sample:

0thers  

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 18 years
最大 Max age 60 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:

不公开/Private

盲法:

Blinding:

None

是否共享原始数据:

IPD sharing

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:

EDC

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

EDC

数据与安全监察委员会:

Data and Safety Monitoring Committee:

无/No

注册人:

Name of Registration:

 2026-02-23 17:55:38