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基于窼嚢内生理论研究活血消窼散抑制冠心病患者斑块内血管内新生的机制
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注册号:

Registration number:

ChiCTR1800015165 

最近更新日期:

Date of Last Refreshed on:

2018-03-11 

注册时间:

Date of Registration:

2018-03-11 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

基于窼嚢内生理论研究活血消窼散抑制冠心病患者斑块内血管内新生的机制 

Public title:

Study on the mechanism of huoxuexiaozheng powder in Inhibiting angiogenesis in patients with coronary heart disease based on the theory of  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于窼嚢内生理论研究活血消窼散抑制冠心病患者斑块内血管新生的机制 

Scientific title:

Study on the mechanism of huoxuexiaozheng powder in Inhibiting angiogenesis in patients with coronary heart disease based on the theory of  

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:

刘强 

研究负责人:

刘强 

Applicant:

Liu Qiang 

Study leader:

Liu Qiang 

申请注册联系人电话:

Applicant telephone:

+86 13588121905 

研究负责人电话:

Study leader's telephone:

+86 13588121905 

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:

13588121905@163.com 

研究负责人电子邮件:

Study leader's E-mail:

13588121905@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:

浙江省杭州市上城区邮电路54号浙江中医药大学附属第一医院心血管科 

研究负责人通讯地址:

浙江省杭州市上城区邮电路54号浙江中医药大学附属第一医院 心血管科 

Applicant address:

54 Youdian Road, Hangzhou, Zhejiang, China 

Study leader's address:

54 Youdian Road, Hangzhou, Zhejiang, China 

申请注册联系人邮政编码:

Applicant postcode:

310006 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

浙江中医药大学附属第一医院 

Applicant's institution:

First Affiliated Hospital of Zhejiang Chinese Medicine University 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2018-K-025-01 

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:

浙江中医药大学附属第一医院伦理委员会 

Name of the ethic committee:

Ethics Committee of the First Affiliated Hospital of Zhejiang Chinese Medicine University 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-07-27 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

浙江省杭州市上城区邮电路54号浙江中医药大学附属第一医院 

Contact Address of the ethic committee:

54 Youdian Road, Hangzhou, Zhejiang, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

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:

浙江中医药大学附属第一医院 

Primary sponsor:

First Affiliated Hospital of Zhejiang Chinese Medicine University 

研究实施负责(组长)单位地址:

浙江省杭州市上城区邮电路54号 

Primary sponsor's address:

54 Youdian Road, Hangzhou, Zhejiang, 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

Province:

Zhejiang

City:

Hangzhou

单位(医院):

浙江中医药大学附属第一医院

具体地址:

浙江省杭州市邮电路54号

Institution
hospital:

First Affiliated Hospital of Zhejiang Chinese Medicine University

Address:

54 Youdian Road, Hangzhou, Zhejiang, China

经费或物资来源:

配套经费 

Source(s) of funding:

Supporting funds 

研究疾病:

冠状动脉粥样硬化性心脏病 

Target disease:

Coronary atherosclerotic heart disease 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

通过采集痰瘀互结型冠心病患者的临床症状、体征和病史等相关信息,集合影像学、血液相关指标等,验证活血消窠散治疗痰瘀互结型冠心病的临床疗效,并初步明确其临床疗效可能通过抑制痰瘀互结型冠心病患者斑块内血管新生而实现。 

Objectives of Study:

By collecting relevant information about the clinical symptoms, physical signs, and medical history of patients with coronary artery disease, and collecting imaging and blood-related indicators, we verified the clinical efficacy of huoxuexiaozheng Powder in the treatment of reciprocal coronary heart disease, and it is clear Its clinical efficacy may be achieved by inhibiting angiogenesis in plaques in patients with spasticity-associated coronary heart disease. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

我院心内科痰瘀互结型冠心病(1)年龄35-85岁; (2)依从性良好,未服用其他中药的患者; (3)平时规律服用他汀药物及抗血小板聚集药物的患者; (4)经告知同意接受病史采集、随访及需要采集空腹12h静脉血标本2次。 

Inclusion criteria

1. Patients aged 35-85 years in the Department of Cardiology in our hospital; 2. Patients with good compliance who have not taken other Chinese medicines; 3. Patients who regularly take statins and anti-platelet aggregation drugs; 4. After informed consent to receive medical history collection, follow-up and need to collect fasting 12h venous blood samples 2 times. 

排除标准:

(1)近 1 周内有感染、发热、创伤、烧伤、手术史的患者或活动性结核病或风湿免疫疾病患者; (2)重度心律失常(快速房颤、房扑、阵发性室速等)伴血流动力学改变; (3)慢性心力衰竭阶段 C 患者(阶段 C 指临床心衰阶段,患者已有基础的结构性心脏病,以往或目前有气短、乏力、运动耐量下降等心衰的症状或体征); (4)心脏瓣膜病(一个瓣膜及以上发生中度病变)或原发性心肌病; (5)慢性阻塞性肺疾病急性加重期或肺心病或呼吸衰竭患者; (6)合并脑血管病急性期和亚急性期的患者; (7)已知的严重肾功能不全,血清肌酐(Cr)男性>221umol/L,女性>177umol/L 者; (8)已知的严重肝功能不全,谷丙转氨酶(ALT)>正常值的 3 倍或合并肝硬化者; (9)合并造血系统或恶性肿瘤等严重原发性疾病; (10)脏器移植患者; (11)孕妇、哺乳期妇女; (12)自身免疫性疾病、甲减或SLE患者; (13)4 周内曾服用免疫调节剂、类固醇激素类药物者。 

Exclusion criteria:

(1) Patients with infection, fever, trauma, burns, surgical history, or active tuberculosis or rheumatic immune disease in the last week; (2) Severe arrhythmia (rapid atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, etc.) with hemodynamic changes; (3) Patients with chronic heart failure stage C (stage C refers to the stage of clinical heart failure, the patient has a basic structural heart disease, past or current symptoms such as shortness of breath, fatigue, decreased exercise tolerance or other signs of heart failure); (4) valvular heart disease (moderate or above a valve) or primary cardiomyopathy; (5) Patients with acute exacerbation of chronic obstructive pulmonary disease or pulmonary heart disease or respiratory failure; (6) patients with acute and subacute cerebrovascular disease; (7) known severe renal insufficiency, serum creatinine (Cr) male> 221umol / L, female> 177umol / L; (8) known severe hepatic insufficiency, alanine aminotransferase (ALT)> 3 times normal, or with cirrhosis; (9) Combining severe primary diseases such as hematopoietic system or malignant tumors; (10) organ transplant patients; (11) Pregnant and lactating women; (12) autoimmune diseases, hypothyroidism or SLE patients; (13) Those who took immunomodulators and steroid hormones within 4 weeks. 

研究实施时间:

Study execute time:

From2018-03-13To 2019-02-20 

干预措施:

Interventions:

组别:

西医治疗组

样本量:

50

Group:

Conventional treatment group

Sample size:

干预措施:

采集患者临床信息及相关检查结果

干预措施代码:

Intervention:

Conventional treatment

Intervention code:

组别:

中西医结合治疗组

样本量:

50

Group:

Integrated traditional Chinese and Western medicine treatment group

Sample size:

干预措施:

活血消窼散

干预措施代码:

Intervention:

huoxuexiaozheng powder

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

国家 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

浙江中医药大学附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

First Affiliated Hospital of Zhejiang Chinese Medicine University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

血管细胞黏附分子-1

指标类型:

主要指标 

Outcome:

VCAM-1

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

微小RNA-126

指标类型:

主要指标 

Outcome:

miRNA-126

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

总胆固醇

指标类型:

主要指标 

Outcome:

TC

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

甘油三酯

指标类型:

主要指标 

Outcome:

TG

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

低密度脂蛋白

指标类型:

主要指标 

Outcome:

LDL-C

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

高密度脂蛋白

指标类型:

主要指标 

Outcome:

HDL-C

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

超敏 C 反应蛋白

指标类型:

主要指标 

Outcome:

Hs-CRP

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

同型半胱氨酸

指标类型:

主要指标 

Outcome:

Hcy

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

西雅图心绞痛量表积分

指标类型:

主要指标 

Outcome:

Seattle Angina Scale 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:

中医症候积分

指标类型:

主要指标 

Outcome:

TCM symptom 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:

总斑块积分

指标类型:

主要指标 

Outcome:

Total plaque 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:

节段狭窄积分

指标类型:

主要指标 

Outcome:

SSS

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:

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 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):

随机数表法

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

Random number table method

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):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

论著报道

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

Report

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:

Excel电子表格

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

Excel

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2018-03-11
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