中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2100041998
最近更新日期： Date of Last Refreshed on：	2021-03-29 16:35:17
注册时间： Date of Registration：	2021-01-12 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	系统挖掘血瘀证血小板功能异常生物学基础的临床研究
Public title：	A clinical study on the biological basis of abnormal platelet function in blood stasis syndrome
注册题目简写：
English Acronym：
研究课题的正式科学名称：	系统挖掘血瘀证血小板功能异常生物学基础的临床研究
Scientific title：	A clinical study on the biological basis of abnormal platelet function in blood stasis syndrome
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：	孙林娟	研究负责人：	刘建勋
Applicant：	Sun Linjuan	Study leader：	Liu Jianxun
申请注册联系人电话： Applicant telephone：	+86 13699279549	研究负责人电话： Study leader's telephone：	+86 13701090121
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：	sunlinjuan888@163.com	研究负责人电子邮件： Study leader's E-mail：	liujx0324@sina.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：	北京市海淀区西苑操场1号	研究负责人通讯地址：	北京市海淀区西苑操场1号
Applicant address：	1 Xiyuan Playground, Haidian District, Beijing, China	Study leader's address：	1 Xiyuan Playground, Haidian District, Beijing, 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：	西苑医院
Applicant's institution：	Xiyuan Hospital
研究负责人所在单位：	西苑医院
Affiliation of the Leader：	Xiyuan Hospital

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：	2020XLA057	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：	中国中医科学院西苑医院医学伦理委员会
Name of the ethic committee：	Medical Ethics Committee of Xiyuan Hospital, China Academy of Chinese Medical Sciences
伦理委员会批准日期： Date of approved by ethic committee：	2020-12-24 00:00:00
伦理委员会联系人：	訾明杰
Contact Name of the ethic committee：	Zi Mingjie
伦理委员会联系地址：	北京市海淀区西苑操场1号
Contact Address of the ethic committee：	1 Xiyuan Caochang Road, Beijing
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：

中国中医科学院西苑医院

Primary sponsor：

Xiyuan Hospital, China Academy of Chinese Medical Sciences

研究实施负责（组长）单位地址：

北京市海淀区西苑操场1号

Primary sponsor's address：

1 Xiyuan Playground, Haidian District, Beijing, 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)：	北京	市(区县)：
Country：	China	Province：	Beijing	City：
单位(医院)：	西苑医院	具体地址：	海淀区西苑操场1号
Institution hospital：	Xiyuan Hospital	Address：	1 Xiyuan Playground, Haidian District

经费或物资来源：

国家自然科学基金委员会

Source(s) of funding：

National Natural Science Foundation of China

研究疾病：

血瘀证

Target disease：

Blood stasis

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：

析因分组（即根据危险因素或暴露因素分组）

Study design：

Factorial

研究目的：

通过多组学技术，挖掘血瘀证的生物标志物，构建以血小板功能为核心的信号调控网络，进一步阐明血瘀证的生物学内涵。

Objectives of Study：

The biomarkers of blood stasis syndrome were mined through multi-group technology, and the signal regulation network with platelet function as the core was constructed, so as to further clarify the biological connotation of blood stasis syndrome.

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

In this study, a total of four groups of subjects were included, namely, patients with atherosclerosis, coronary heart disease and cerebral infarction with syndrome differentiation of blood stasis, and normal subjects were taken as the unified control group.
The disease group first met the common inclusion criteria:
(1) Age 40-85 (including boundary age), regardless of gender;
(2) TCM syndrome of blood stasis or qi deficiency and blood stasis;
(3) Imaging examination showed evidence of arterial intima thickening or plaque
(4) those who have never used or have not used antiplatelet/anticoagulant drugs regularly;
(5) Participate voluntarily and sign informed consent.
Inclusion criteria for atherosclerosis subjects:
(1) Meet the diagnostic criteria of atherosclerosis with hyperlipidemia;
(2) Patients with IMT >= 1.0mm or visible plaque, and the degree of carotid artery stenosis < 70%.
Inclusion criteria for coronary heart disease group:
(1) Meet the western medical diagnostic criteria for coronary heart disease, angina pectoris or chronic heart failure;
(2) diagnosis includes coronary heart disease angina, unstable angina, acute phase, each stage after interventional therapy and coronary heart disease, heart failure, and heart function class for II - III.
Inclusion criteria for cerebral infarction group:
(1) Meet the diagnostic criteria of atherosclerotic thrombotic cerebral infarction;
(2) Carotid artery color ultrasound showed evidence of atherosclerotic plaque, and CT/MRI showed clear infarction foci;
(3) NIHSS score >= 2 and <= 33.
Inclusion criteria of normal control group:
(1) Ages 40-85, regardless of gender;
(2) TCM syndrome differentiation without deficiency of qi and blood stasis;
(3) There were no abnormalities in routine physical examination, vital signs (temperature, blood pressure, heart rate, respiration), electrocardiogram and laboratory examination (including blood, urine, stool routine, liver, renal function and other biochemical indicators);
(4) Medical history of centerless blood, lung, liver, kidney, digestive tract, nervous system, blood system, mental disorders, metabolic abnormalities that affect the coagulation function.
(5) No recent trauma or surgical history;
(6) Recently did not take anti-platelet drugs, steroids or non-steroidal anti-inflammatory drugs;
(7) Did not participate in other drug clinical trials within 1 month.
(8) Voluntary and signed informed consent.

排除标准：

疾病组排除标准：
有下列情况之一者：急性冠脉综合征（30天内）、心源性休克、药物难以控制的高血压（收缩压≥180mmHg和/或舒张压≥110mmHg）、Ⅱ度Ⅱ型以上窦房或房室传导阻滞未置入起搏器治疗、难以控制的恶性心律失常、肥厚梗阻性心肌病、急性心肌炎、肺动脉栓塞、严重瓣膜疾病、蛛网膜下腔出血和脑出血，由于脑肿瘤、（1）脑外伤、血液病等引起的卒中患者以及重度神经官能症等；
（2）合并有呼吸系统、神经系统、消化道系统、血液系统（如中至重度贫血、血小板增多症、血小板功能缺陷病等）、内分秘系统以及免疫系统（如类风湿关节炎、系统性红斑狼疮、血小板减少症等）等严重疾病，以及恶性肿瘤患者，有严重创伤、感染患者或近一个月内有深部血管穿刺或外科手术病史等；
（3）严重肝肾功能损害者，谷丙转氨酶/谷草转氨酶＞3倍正常值上限，血清肌酐大于上限者；
（4）随机血糖≥13.7mmol/L的糖尿病患者或糖化血红蛋白≥8%；
（5）中医辨证合并有较明显的阴虚或阳虚者；
（6）育龄妇女处于妊娠或者哺乳期者；
（7）近1个月内参加过或正在参加其他临床实验者；
（8）精神、神经障碍，不能正确表达意愿者；
（9）酗酒者以及药物滥用及成瘾者。
正常对照组排除标准：
（1）合并有血液系统、免疫系统等其他重大系统性疾病，或恶性肿瘤患者，过敏体质或有严重创伤、感染患者等；
（2）高血压、糖尿病等慢性疾病控制不良者；
（3）育龄妇女处于妊娠或哺乳期者；
（4）精神、神经障碍，不能正确表达意愿者；
（5）酗酒者以及药物滥用及成瘾者。

Exclusion criteria：

Exclusion criteria for disease group:
Has one of the following circumstances: acute coronary syndrome (30 days), cardiac shock, drugs are difficult to control high blood pressure (systolic blood pressure or greater 180 MMHG and/or diastolic blood pressure, 110 MMHG or higher), Ⅱ Ⅱ degrees above sinus or atrioventricular block placement pacemaker therapy, difficult to control the malignant arrhythmia and hypertrophic obstructive cardiomyopathy, acute myocarditis, pulmonary embolism, severe valvular disease and cerebral hemorrhage, subarachnoid hemorrhage, because brain tumor, (1) the brain injury, blood disease caused by stroke patients and severe neurosis;
(2) with the respiratory system, nervous system, digestive system, blood system, such as to severe anemia, thrombocytosis in disease, platelet function defect disease, etc.), the production system and the immune system, such as rheumatoid arthritis and systemic lupus erythematosus (sle), thrombocytopenia, etc.), such as serious illness, and malignant tumor patients, patients with severe trauma, infection, or nearly a month has a deep history of vascular puncture or surgery, etc.;
(3) in patients with severe liver and kidney function impairment, the upper limit of alanine aminotransferase/alanine aminotransferase > was 3 times of normal value, and the serum creatinine was higher than the upper limit;
(4) Diabetic patients with random blood glucose ≥13.7mmol/L or hemoglobin a1c ≥8%;
(5) TCM syndrome differentiation combined with more obvious Yin deficiency or Yang deficiency;
(6) a woman of childbearing age is pregnant or breast-feeding;
(7) Have participated in or are participating in other clinical subjects in the past 1 month;
(8) Persons with mental or neurological disorders and unable to express their wishes correctly;
(9) Alcoholics and drug abusers and addicts.
Exclusion criteria for normal control group:
(1) Patients with blood system, immune system and other major systemic diseases, or malignant tumors, allergic constitution, or patients with severe trauma or infection;
(2) Persons with poor control of chronic diseases such as hypertension and diabetes;
(3) Women of childbearing age are pregnant or lactating;
(4) Persons with mental or neurological disorders and unable to express their wishes correctly;
(5) Alcoholics and drug abusers and addicts.

研究实施时间：

Study execute time：

从 From 2021-01-01 00:00:00至 To 2021-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2021-01-01 00:00:00 至 To 2021-12-31 00:00:00

干预措施：

Interventions：

组别：	正常对照组	样本量：	50
Group：	Normal control group	Sample size：	50
干预措施：	无	干预措施代码：
Intervention：	None	Intervention code：

组别：	脑梗死组	样本量：	50
Group：	Cerebral infarction group	Sample size：	50
干预措施：	无	干预措施代码：
Intervention：	None	Intervention code：

组别：	冠心病组	样本量：	50
Group：	Coronary heart disease group	Sample size：	50
干预措施：	无	干预措施代码：
Intervention：	None	Intervention code：

组别：	动脉粥样硬化组	样本量：	50
Group：	Atherosclerosis group	Sample size：	50
干预措施：	无	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(区县)：
Country：	China	Province：	Beijing	City：
单位(医院)：	西苑医院	单位级别：	三级甲等
Institution hospital：	Xiyuan Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	血小板聚集实验	指标类型：	主要指标
Outcome：	Platelet aggregation experiment	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		岁 years
最大 Max age		岁 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）：

不适用

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

N/A

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：	N/A
Blinding：	N/A

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）：	自建数据库平台请阅读网页注册指南中关于原始数据共享的内容。
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Self-built database platform
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：	研究人员将数据填写到病例报告表中，研究协调员会定期检查数据的真实性和可靠性。然后由专人将案件报告表的数据输入电子数据库，并通过两次输入确保数据的可靠性。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	The data are filled out by the researchers to the case report form, and the research coordinator regularly checked the authenticity and reliability of the data. The data of the case report form is then entered into the electronic database by the specially-aasigned person, and the reliability of the data is ensured by double entering.
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：	2021-01-12 00:15:50