乙酰肝素酶(HPSE)和髓样分化初级反应因子88(Myd88)等新型血清学标志物与心肌缺血再灌注后心室重构、心肌纤维化及线粒体自噬的相关性研究

注册号:

Registration number:

ChiCTR2600125987 

最近更新日期:

Date of Last Refreshed on:

2026-06-02 09:42:39 

注册时间:

Date of Registration:

2026-06-02 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

乙酰肝素酶(HPSE)和髓样分化初级反应因子88(Myd88)等新型血清学标志物与心肌缺血再灌注后心室重构、心肌纤维化及线粒体自噬的相关性研究

Public title:

Study on the Correlation between Heparanase and Ventricular Remodeling, Myocardial Fibrosis and Mitochondrial Autophagy after Myocardial Ischemia-reperfusion

注册题目简写:

乙酰肝素酶(HPSE)和Myd88等新型血清学标志物与心肌缺血再灌注后心室重构、心肌纤维化及线粒体自噬的相关性研究

English Acronym:

Study on the Correlation between Heparanase and Ventricular Remodeling, Myocardial Fibrosis and Mitochondrial Autophagy after Myocardial Ischemia-reperfusion

研究课题的正式科学名称:

乙酰肝素酶(HPSE)和Myd88等新型血清学标志物与心肌缺血再灌注后心室重构、心肌纤维化及线粒体自噬的相关性研究

Scientific title:

Study on the Correlation between Heparanase and Ventricular Remodeling, Myocardial Fibrosis and Mitochondrial Autophagy after Myocardial Ischemia-reperfusion

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:

杨硕 

研究负责人:

晋群 

Applicant:

Shuo Yang 

Study leader:

Qun Jin 

申请注册联系人电话:

Applicant telephone:

+86 198 6117 2738

研究负责人电话:

Study leader's
telephone:

+86 138 6400 3305

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:

19861172738@163.com

研究负责人电子邮件:

Study leader's E-mail:

jinqun1998@163.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:

中国山东省济南市天桥区师范路25号

研究负责人通讯地址:

中国山东省济南市天桥区师范路25号

Applicant address:

No. 25, Shengyu Road, Tianqiao District, Jinan, Shandong, China

Study leader's address:

No. 25, Shengyu Road, Tianqiao District, Jinan, Shandong, 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:

中国人民解放军联勤保障部队第九六〇医院

Applicant's institution:

The 960 Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army

研究负责人所在单位:

中国人民解放军联勤保障部队第九六〇医院

Affiliation of the Leader:

The 960 Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army

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:

(2026)科研伦理审第(060)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:

中国人民解放军联勤保障部队第九六〇医院医学伦理委员会

Name of the ethic committee:

The Medical Ethics Committee of the 960 Hospital of the Joint Support Force of the People's Liberation Army of China

伦理委员会批准日期:

Date of approved by ethic committee:

2026-04-14 00:00:00

伦理委员会联系人:

孙志东

Contact Name of the ethic committee:

Zhidong Sun

伦理委员会联系地址:

中国山东省济南市天桥区师范路25号

Contact Address of the ethic committee:

No. 25, Shengyu Road, Tianqiao District, Jinan, Shandong, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 531 5166 6145

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:

中国人民解放军联勤保障部队第九六〇医院

Primary sponsor:

The 960 Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army

研究实施负责(组长)单位地址:

中国山东省济南市天桥区师范路25号

Primary sponsor's address:

No. 25, Shengyu Road, Tianqiao District, Jinan, Shandong, 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):

山东

市(区县):

Country:

China

Province:

Shandong

City:

单位(医院):

中国人民解放军联勤保障部队第九六〇医院

具体地址:

中国山东省济南市天桥区师范路25号

Institution
hospital:

The 960 Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army

Address:

No. 25, Shengyu Road, Tianqiao District, Jinan, Shandong, China

经费或物资来源:

潍坊医学院附属医院科技发展项目

Source(s) of funding:

Science and Technology Development Project of Affiliated Hospital of Weifang Medical University

研究疾病:

心肌缺血再灌注、心室重构、心肌纤维化  

Target disease:

Myocardial ischemia-reperfusion, ventricular remodeling, myocardial fibrosis

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:

其它 

Study phase:

N/A

研究设计:

队列研究 

Study design:

Cohort study 

研究目的:

研究HPSE的表达水平与心肌缺血再灌注后心室重构、心肌纤维化及主要不良心血管事件的相关性,结合动物实验和临床试验,为评估MIR后心室重构、近远期预后提供新的生物学标志物和科学依据  

Objectives of Study:

The study aims to investigate the correlation between the expression level of HPSE and ventricular remodeling, myocardial fibrosis, and major adverse cardiovascular events after myocardial ischemia-reperfusion. By combining animal experiments and clinical trials, it seeks to provide new biological markers and scientific evidence for evaluating ventricular remodeling and short-term and long-term prognosis after MIR.

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.不符合纳入标准; 2.严重的心血管疾病或肺疾病、肝肾功能不全、重度感染、恶性肿瘤; 3.对试验相关药物过敏,近期使用过可能影响HPSE水平的药物,如抗凝药、抗血小板药、抗炎药等; 4.近期有心肌梗死病史、接受过PCI或其他心脏手术,其HPSE水平可能处于异常状态; 5.妊娠或哺乳期妇女、精神或神经系统疾病无法配合完成研究;临床资料不完整。符合以上任意一项即排除。

Exclusion criteria:

1.Does not meet the inclusion criteria. 2.Severe cardiovascular or pulmonary diseases, liver or kidney dysfunction, severe infections, malignant tumors. 3.Allergic to the drugs related to the trial, having used drugs that may affect the level of HPSE recently, such as anticoagulants, antiplatelet drugs, anti-inflammatory drugs, etc. 4.Has a recent history of myocardial infarction, has undergone PCI or other cardiac surgeries, and the level of HPSE may be in an abnormal state. 5.Pregnant or lactating women, those with mental or neurological disorders who cannot cooperate to complete the study; incomplete clinical data. Any one of the above conditions will result in exclusion.

研究实施时间:

Study execute time:

From 2024-08-01 00:00:00 To 2027-06-30 00:00:00  

征募观察对象时间:

Recruiting time:

From 2026-06-02 00:00:00 To 2027-06-30 00:00:00

干预措施:

Interventions:

组别:

心肌缺血再灌注后心室重构组

样本量:

100

Group:

The ventricular remodeling group after myocardial ischemia-reperfusion

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

组别:

心肌缺血再灌注后非心室重构组

样本量:

100

Group:

The non-ventricular remodeling group after myocardial ischemia-reperfusion

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):

山东 

市(区县):

 

Country:

China

Province:

Shandong

City:

单位(医院):

中国人民解放军联勤保障部队第九六〇医院 

单位级别:

三甲 

Institution
hospital:

The 960 Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

乙酰肝素酶

指标类型:

主要指标

Outcome:

Heparanase

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

N端脑钠肽前体

指标类型:

次要指标

Outcome:

N-terminal pro-brain natriuretic peptide

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血清可溶性生长刺激表达基因2蛋白

指标类型:

次要指标

Outcome:

Soluble growth-stimulating expression gene 2 protein

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

基质金属蛋白酶-9

指标类型:

次要指标

Outcome:

Matrix Metallopeptidase-9

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:

血液

组织:

Sample Name:

Blood

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 18 years
最大 Max age 100 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:

病例记录本

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

Case record book

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:

 2026-06-02 09:42:34