A cohort study of patients after PCI for coronary heart disease

注册号:

Registration number:

ITMCTR2025000059

最近更新日期:

Date of Last Refreshed on:

2025-01-10

注册时间:

Date of Registration:

2025-01-10

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

基于“瘀毒郁互结”冠心病PCI术后中医精准治疗现代诠释和临床应用研究

Public title:

A cohort study of patients after PCI for coronary heart disease

注册题目简写:

冠心病PCI术后患者的队列研究

English Acronym:

Cohort study of patients after PCI for coronary heart disease

研究课题的正式科学名称:

基于中医病机理论的重大疾病现代诠释及临床应用研究-基于“瘀毒郁互结”冠心病PCI术后中医精准治疗现代诠释和临床应用研究

Scientific title:

A study of contemporary interpretation and clinical implementation of major diseases through the lens of Chinese medicine mechanism theory is imperative. An investigation into the modern interpretation and clinical application of precision treatment for coronary heart disease PCI (percutaneous coronary intervention) based on the theory of "stasis toxicity and depression mutually conjugated" is necessary

研究课题的正式科学名称简写:

Scientific title acronym:

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:

王洁宜

研究负责人:

陈启兰

Applicant:

Jieyi Wang

Study leader:

Qilan Chen

申请注册联系人电话:

Applicant telephone:

15967134896

研究负责人电话:

Study leader's telephone:

13588750941

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:

zjzyywjy@outlook.com

研究负责人电子邮件:

Study leader's E-mail:

1469013813@qq.com

申请单位网址(自愿提供):

Study leader's 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:

浙江杭州滨江区滨文路548号浙江中医药大学

研究负责人通讯地址:

浙江杭州市西湖区体育场路453号

Applicant address:

Street Binwen No.548 Region Binjiang hangzhou zhejiang

Study leader's address:

No.453 Stadium Road Xihu District Hangzhou Zhejiang China

申请注册联系人邮政编码:

Applicant postcode:

310000

研究负责人邮政编码:

Study leader's postcode:

310000

申请人所在单位:

浙江中医药大学

Applicant's institution:

Zhejiang Chinese Medical University

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

2024LL046

伦理委员会批件附件:

Approved file of Ethical Committee:

View

批准本研究的伦理委员会名称:

杭州市中医院临床研究伦理委员会

Name of the ethic committee:

Clinical Research Ethics Committee of Hangzhou Hospital of Traditional Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2024/12/16 0:00:00

伦理委员会联系人:

张来

Contact Name of the ethic committee:

Lai Zhang

伦理委员会联系地址:

杭州市体育场路453号

Contact Address of the ethic committee:

No. 453 Stadium Road Hangzhou

伦理委员会联系人电话:

Contact phone of the ethic committee:

0571-85827896

伦理委员会联系人邮箱:

Contact email of the ethic committee:

zjhzszyy@126.com

研究实施负责(组长)单位:

杭州市中医院

Primary sponsor:

Hangzhou Hospital of Traditional Chinese Medicine

研究实施负责(组长)单位地址:

浙江省杭州市西湖区体育场路453号

Primary sponsor's address:

453 Stadium Road Xihu District Hangzhou City Zhejiang 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):

浙江

市(区县):

杭州

Country:

China   中国

Province:

zhejiang

City:

hangzhou

单位(医院):

浙江中医药大学

具体地址:

浙江杭州滨江区滨文路548号浙江中医药大学

Institution
hospital:

Zhejiang Chinese Medical University

Address:

Street Binwen No.548 Region Binjiang hangzhou zhejiang

经费或物资来源:

浙江省科学技术厅““尖兵领雁+X”研发攻关计划”(NO.2024C03192)

Source(s) of funding:

Zhejiang Provincial Department of Science and Technology Sharp Soldier Leader + X R&D Program (NO.2024C03192)

研究疾病:

冠心病

研究疾病代码:

Target disease:

coronary heart disease

Target disease code:

研究类型:

Study type:

治疗研究

Treatment study

研究设计:

Study design:

队列研究

Cohort study

研究所处阶段:

Study phase:

其它

Others

研究目的:

为推广CHD中西医结合疗法的临床实践提供高质量科学依据。

Objectives of Study:

To provide a high quality scientific basis for promoting the clinical practice of combined Chinese and Western medicine therapy for CHD.

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冠心病诊断需符合诊断标准; ②经皮冠状动脉支架植入术后<3个月,且常规西医治疗的冠心病患者; ③心功能分级NYHA为I- II级且射血分数≥45% ④中老年人群(年龄45-80岁)

Inclusion criteria

①Diagnosis of coronary heart disease needs to meet the diagnostic criteria; ② Patients with coronary artery disease <3 months after percutaneous coronary stent implantation and under conventional western medical treatment; ③Cardiac function classification NYHA class I-II and ejection fraction ≥45%. ④ Middle-aged and elderly people (age 45-80 years old)

排除标准:

①cTNI>0.4 ug/L ②服用精神类药物者 ③合并高血压控制不良(≥180/100mmHg)或低血压(<90/60mmHg) ④合并恶性心律失常近期反复发作者 ⑤合并严重肝肾功能障碍、其他影响寿命的严重原发疾病、肿瘤或严重精神性疾病 ⑥近6个月内发生卒中者 ⑦妊娠、计划妊娠或哺乳期妇女 ⑧己知出血倾向或出血性疾病,或难以控制的凝血机制障碍,或2周内有活动性出血和有创检查治疗操作术,或12周内有严重创伤或大手术史 ⑨正在参加其它临床试验,或对试验用药物及其组成成分过敏者 ⑩目前或既往药物滥用史或吸毒史 ⑪患有痴呆或严重精神障碍改变使其不能理解或表达知情同意者 ⑫ 有药物或酒精依赖者,或研究者认为不宜参加本研究的其他情况

Exclusion criteria:

①cTNI >0.4 ug/L ②Psychotropic drug users ③ Combined poorly controlled hypertension (≥180/100mmHg) or hypotension (<90/60mmHg). ④ Combined with malignant arrhythmia with recent recurrence. ⑤ Combination of severe liver and kidney dysfunction other serious primary diseases that affect life expectancy tumors or severe mental illnesses ⑥Those who have had a stroke within the last 6 months. ⑦Pregnant planning to be pregnant or breastfeeding women. ⑧Known bleeding tendency or bleeding disorder or uncontrollable coagulation disorders or active bleeding and invasive examination and treatment operations within 2 weeks or severe trauma or history of major surgery within 12 weeks ⑨ Participating in other clinical trials or allergic to experimental drugs and their constituents ⑩History of current or past substance abuse or drug addiction ⑪ Those who have dementia or serious mental disorder that prevents them from understanding or expressing informed consent. ⑫ Persons with drug or alcohol dependence or other conditions t

研究实施时间:

Study execute time:

From 2025-01-14

To      2025-12-16

征募观察对象时间:

Recruiting time:

From 2025-01-14

To      2025-12-16

干预措施:

Interventions:

组别:

瘀毒郁-常规西药+血塞通组

样本量:

120

Group:

Stasis and Toxicity Depression-Conventional Western Medicine+Xuesaitong Group

Sample size:

干预措施:

常规西药+血塞通组

干预措施代码:

Intervention:

Western Medicine+Xuesaitong

Intervention code:

组别:

瘀毒郁-常规西药组

样本量:

120

Group:

blood stasis and toxic depression-conventional western medicine group

Sample size:

干预措施:

常规西药

干预措施代码:

Intervention:

conventional western medicine

Intervention code:

组别:

瘀毒郁-常规西药+黄金双参加味颗粒组

样本量:

120

Group:

Stasis and Toxicity Depression-Conventional Western Medicine+HJSSJW Group

Sample size:

干预措施:

常规西药+黄金双参加味颗粒

干预措施代码:

Intervention:

Western Medicine+HJSSJW

Intervention code:

组别:

非瘀毒郁-常规西药组

样本量:

120

Group:

Non-blood stasis and toxic depression-conventional western medicine group

Sample size:

干预措施:

常规西药

干预措施代码:

Intervention:

conventional western medicine

Intervention code:

样本总量 Total sample size : 480

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

浙江

市(区县):

杭州

Country:

China

Province:

zhejiang

City:

单位(医院):

杭州市临平区第一人民医院

单位级别:

三乙

Institution/hospital:

The First People's Hospital of Linping District Hangzhou

Level of the institution:

Grade 3B

国家:

中国

省(直辖市):

浙江

市(区县):

杭州

Country:

China

Province:

zhejiang

City:

hangzhou

单位(医院):

杭州师范大学附属医院

单位级别:

三甲

Institution/hospital:

Hospital of Hangzhou Normal University

Level of the institution:

Grade 3A

国家:

中国

省(直辖市):

辽宁

市(区县):

沈阳

Country:

China

Province:

liaoning

City:

shenyang

单位(医院):

辽宁中医药大学附属医院

单位级别:

三甲

Institution/hospital:

Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Level of the institution:

Grade 3A

国家:

中国

省(直辖市):

辽宁

市(区县):

大连

Country:

China

Province:

liaoning

City:

dalian

单位(医院):

大连医科大学附属第二医院

单位级别:

三甲

Institution/hospital:

The Second Hospital of Dalian Medical University

Level of the institution:

Grade 3A

测量指标:

Outcomes:

指标中文名:

重大不良心血管事件

指标类型:

主要指标

Outcome:

Major Adverse Cardiovascular Events

Type:

Primary indicator

测量时间点:

12,24,36,48周

测量方法:

随访询问

Measure time point of outcome:

12 24 36 48 weeks

Measure method:

Follow-up inquiries

指标中文名:

支架内再狭窄

指标类型:

次要指标

Outcome:

Intra-stent restenosis

Type:

Secondary indicator

测量时间点:

48周

测量方法:

冠脉CTA/CAG

Measure time point of outcome:

48 weeks

Measure method:

Coronary CTA/CAG

指标中文名:

汉密尔顿焦虑量表

指标类型:

次要指标

Outcome:

Hamilton Anxiety Inventory

Type:

Secondary indicator

测量时间点:

4 8 12 24 36 48 周

测量方法:

问卷采集

Measure time point of outcome:

4 8 12 24 36 48 weeks

Measure method:

questionnaire collection

指标中文名:

左心室舒张末期容积指数

指标类型:

次要指标

Outcome:

Left ventricular end-diastolic volume index

Type:

Secondary indicator

测量时间点:

12和48周

测量方法:

心脏超声检查

Measure time point of outcome:

12 and 48 weeks

Measure method:

Cardiac ultrasound

指标中文名:

血脂四项

指标类型:

次要指标

Outcome:

lipids

Type:

Secondary indicator

测量时间点:

4 8 12 24 36 48 周

测量方法:

血液检查

Measure time point of outcome:

4 8 12 24 36 48 weeks

Measure method:

blood test

指标中文名:

汉密尔顿抑郁量表

指标类型:

次要指标

Outcome:

Hamilton Depression Scale

Type:

Secondary indicator

测量时间点:

4 8 12 24 36 48 周

测量方法:

问卷采集

Measure time point of outcome:

4 8 12 24 36 48 weeks

Measure method:

questionnaire collection

指标中文名:

临床结局(心源性死亡、支架内再狭窄、因复发性心绞痛/急性冠脉综合征/心衰/恶性心律失常入院治疗、卒中/TIA)

指标类型:

次要指标

Outcome:

Clinical outcomes (cardiac death in-stent restenosis admission for recurrent angina/acute coronary syndrome/heart failure/malignant arrhythmia stroke/TIA)

Type:

Secondary indicator

测量时间点:

12 24 36 48周

测量方法:

随访询问

Measure time point of outcome:

12 24 36 48 weeks

Measure method:

Follow-up inquiries

指标中文名:

中医证候积分

指标类型:

主要指标

Outcome:

Chinese Medicine Score

Type:

Primary indicator

测量时间点:

4,8,12,24,36,48周

测量方法:

问卷采集

Measure time point of outcome:

4 8 12 24 36 48 weeks

Measure method:

questionnaire collection

指标中文名:

匹兹堡睡眠质量指数量表

指标类型:

次要指标

Outcome:

Pittsburgh Sleep Quality Index Scale

Type:

Secondary indicator

测量时间点:

4 8 12 24 36 48 周

测量方法:

问卷采集

Measure time point of outcome:

4 8 12 24 36 48 weeks

Measure method:

questionnaire collection

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:

标本中文名:

粪便

组织:

Sample Name:

Faeces

Tissue:

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note:

标本中文名:

尿液

组织:

Sample Name:

Urine

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:

尚未开始

Not yet recruiting

年龄范围:

最小 45
Min age years
最大 80
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

队列研究,无随机

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

Cohort study not randomized

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:

我们采用病例记录表和电子采集和管理系统(www.nextedc.cn)同时进行数据采集和管理

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

We use a case record form and an electronic collection and management system(www.nextedc.cn) for simultaneous data collection and management.

数据管理委员会:

Data Managemen Committee:

暂未确定

Not yet

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above