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Research on Traditional Chinese Medicine Health Detection Equipment for the Characteristics of Nailfold Microcirculation in the Risk of Progression from Hyperlipidemia to Cardiovascular and Cerebrovascular Diseases

注册号：

Registration number：

ITMCTR2025000472

最近更新日期：

Date of Last Refreshed on：

2025-03-06

注册时间：

Date of Registration：

2025-03-06

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

高脂血症向心脑血管疾病结局进展风险的甲襞微循环特征中医健康检测装备研究

Public title：

Research on Traditional Chinese Medicine Health Detection Equipment for the Characteristics of Nailfold Microcirculation in the Risk of Progression from Hyperlipidemia to Cardiovascular and Cerebrovascular Diseases

注册题目简写：

English Acronym：

研究课题的正式科学名称：

高脂血症向心脑血管疾病结局进展风险的甲襞微循环特征中医健康检测装备研究

Scientific title：

Research on Traditional Chinese Medicine Health Detection Equipment for the Characteristics of Nailfold Microcirculation in the Risk of Progression from Hyperlipidemia to Cardiovascular and Cerebrovascular Diseases

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：

邹雨童

研究负责人：

杨志敏

Applicant：

Yutong Zou

Study leader：

Zhimin Yang

申请注册联系人电话：

Applicant telephone：

13126466740

研究负责人电话：

Study leader's telephone：

13822296363

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：

1592746415@qq.com

研究负责人电子邮件：

Study leader's E-mail：

yangyovip@126.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：

广东省广州市越秀区光塔街道海珠中路88号广东省中医院(大德路总院)研修楼7楼

研究负责人通讯地址：

广东省广州市越秀区光塔街道海珠中路88号广东省中医院(大德路总院)研修楼7楼

Applicant address：

7th Floor Research Building Guangdong Provincial Hospital of Traditional Chinese Medicine (Headquarters on Dade Road) No. 88 Middle Haizhu Road Guangta Street Yuexiu District Guangzhou City Guangdong Province

Study leader's address：

7th Floor Research Building Guangdong Provincial Hospital of Traditional Chinese Medicine (Headquarters on Dade Road) No. 88 Middle Haizhu Road Guangta Street Yuexiu District Guangzhou City Guangdong Province

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：

广东省中医院

Applicant's institution：

Guangdong Provincial Hospital of Traditional Chinese Medicine

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：

BE2023-331-01

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：

广东省中医院伦理委员会

Name of the ethic committee：

Ethics Committee of Guangdong Provincial Hospital of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2023/12/20 0:00:00

伦理委员会联系人：

李晓彦

Contact Name of the ethic committee：

Xiaoyan LI

伦理委员会联系地址：

广东省广州市越秀区光塔街道海珠中路88号广东省中医院(大德路总院)研修楼19楼

Contact Address of the ethic committee：

19th Floor Research Building Guangdong Provincial Hospital of Traditional Chinese Medicine (Headquarters on Dade Road) No. 88 Middle Haizhu Road Guangta Street Yuexiu District Guangzhou City Guangdong Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

020-81887233转35943

伦理委员会联系人邮箱：

Contact email of the ethic committee：

1592746415@qq.com

研究实施负责（组长）单位：

广东省中医院

Primary sponsor：

Guangdong Provincial Hospital of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

广东省广州市越秀区光塔街道海珠中路88号广东省中医院(大德路总院)研修楼7楼

Primary sponsor's address：

7th Floor Research Building Guangdong Provincial Hospital of Traditional Chinese Medicine (Headquarters on Dade Road) No. 88 Middle Haizhu Road Guangta Street Yuexiu District Guangzhou City Guangdong Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

广东省

市(区县)：

广州市

Country：

China

Province：

Guangdong Province

City：

Guangzhou

单位(医院)：

广东省中医院

具体地址：

广东省广州市越秀区光塔街道海珠中路88号广东省中医院(大德路总院)研修楼7楼

Institution
hospital：

Guangdong Provincial Hospital of Traditional Chinese Medicine

Address：

7th Floor Research Building Guangdong Provincial Hospital of Traditional Chinese Medicine (Headquarters on Dade Road) No. 88 Middle Haizhu Road Guangta Street Yuexiu District Guangzhou City Guangdong Province

经费或物资来源：

广州市重点研发计划项目

Source(s) of funding：

Key Research and Development Program Project of Guangzhou City

研究疾病：

脑卒中、冠心病、原发性高血压、2型糖尿病、慢性肾脏病、高脂血症

研究疾病代码：

Target disease：

Stroke Coronary Heart Disease Essential Hypertension Type 2 Diabetes Mellitus Chronic Kidney Disease Hyperlipidemia

Target disease code：

研究类型：

Study type：

观察性研究

Observational study

研究设计：

Study design：

横断面

Cross-sectional

研究所处阶段：

Study phase：

探索性研究/预试验

Pilot clinical trial

研究目的：

脑卒中和缺血性心脏病等心脑血管疾病具有共同的危险因素和病理基础，对危险因素的一级预防可有效延缓或避免心脑血管事件发生。其中，高脂血症、高血压、糖尿病等是重要且可改变的危险因素。微血管病变与心脏/脑血管及外周等多器官多系统密切相关，甲襞是人体内构型最简单的毛细血管，对心脑血管疾病的早期诊断具有重大潜力。本研究拟基于甲襞微循环宽场显微成像检测技术，通过融合中医原创思维的甲襞微循环图像特征分析判断和微循环形态、动态特征检测识别、大数据和人工智能图像特征分析方法，实现高脂血症、高血压、糖尿病及冠心病、脑卒中的甲襞微循环特征识别，构建高脂血症向心脑血管疾病结局进展风险的中医分级评估模型，形成面向市场的治未病健康检测装备。

Objectives of Study：

Cardiovascular and cerebrovascular diseases such as stroke and ischemic heart disease share common risk factors and pathological bases. Primary prevention of these risk factors can effectively delay or avoid the occurrence of cardiovascular and cerebrovascular events. Among them hyperlipidemia hypertension diabetes and so on are important and modifiable risk factors. Microvascular lesions are closely related to multiple organs and systems such as the heart cerebrovascular system and periphery. The nailfold is the capillary with the simplest structure in the human body and has great potential for the early diagnosis of cardiovascular and cerebrovascular diseases. This study intends to base on the wide-field microscopic imaging detection technology of nailfold microcirculation. Through the analysis and judgment of the image features of nailfold microcirculation integrating the original thinking of traditional Chinese medicine the detection and recognition of the morphological and dynamic features of microcirculation as well as the analysis methods of big data and artificial intelligence image features it aims to achieve the identification of the characteristics of nailfold microcirculation in hyperlipidemia hypertension diabetes coronary heart disease and stroke. Then a hierarchical assessment model of traditional Chinese medicine for the risk of progression from hyperlipidemia to cardiovascular and cerebrovascular diseases will be constructed and health detection equipment for preventive treatment oriented to the market will be formed.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

观察组： （1）年龄≥18岁，性别不限； （2）第一诊断符合以下其中任意一种西医疾病诊断标准： ①脑卒中 ②冠心病 ③原发性高血压 ④2型糖尿病 ⑤慢性肾脏病 ⑥高脂血症 （3）意识清楚、生命体征平稳，无智力障碍、能进行简单有效的沟通； （4）了解试验并自愿签署知情同意书。

Inclusion criteria

Observation Group: (1) Age ≥ 18 years old regardless of gender; (2) The first diagnosis conforms to any one of the following diagnostic criteria for Western medical diseases: ① Stroke ② Coronary heart disease ③ Essential hypertension ④ Type 2 diabetes mellitus ⑤ Chronic kidney disease ⑥ Hyperlipidemia (3) Conscious with stable vital signs no intellectual disability and able to conduct simple and effective communication; (4) Understanding the trial and voluntarily signing the informed consent form.

排除标准：

（1）继发性高血压患者； （2）合并严重基础疾病如严重心力衰竭、脓毒性休克、恶性肿瘤、严重肝肾疾病、高血压急症、糖尿病急性并发症、不稳定型心绞痛、重症感染等；或患有慢性疾病目前处于急性发作期的患者； （3）合并神经、精神、心理疾患无法合作者，或不愿合作者； （4）手指、指甲外伤，严重皮肤疾病或皮肤损伤，手指缺如的患者； （5）孕妇或哺乳期患者。

Exclusion criteria：

(1) Patients with secondary hypertension; (2) Patients with severe underlying diseases such as severe heart failure septic shock malignant tumors severe liver and kidney diseases hypertensive emergencies acute complications of diabetes unstable angina pectoris severe infections etc.; or patients with chronic diseases who are currently in the acute exacerbation stage; (3) Patients with neurological psychiatric or psychological disorders who are unable to cooperate or are unwilling to cooperate; (4) Patients with finger or nail injuries severe skin diseases or skin injuries or with missing fingers; (5) Pregnant or lactating patients.

研究实施时间：

Study execute time：

从From 2024-01-01

至To      2026-12-01

征募观察对象时间：

Recruiting time：

从From 2024-01-01

至To      2026-12-01

干预措施：

Interventions：

组别：

观察组

样本量：

600

Group：

observation group

Sample size：

干预措施：

甲襞微循环检测

干预措施代码：

Intervention：

nailfold microcirculation examination

Intervention code：

样本总量 Total sample size ： 600

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

广东省

市(区县)：

Country：

China

Province：

Guangdong Provincial Hospital of Traditional Chinese Medicine

City：

单位(医院)：

广东省中医院

单位级别：

三甲医院

Institution/hospital：

Guangdong Provincial Hospital of Traditional Chinese Medicine

Level of the institution：

Class III Grade A hospital

测量指标：

Outcomes：

指标中文名：

甲襞微循环检测

指标类型：

主要指标

Outcome：

Nailfold microcirculation detection

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

中医经络检测

指标类型：

次要指标

Outcome：

Detection of traditional Chinese medicine meridians

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

人体磁感应测量

指标类型：

次要指标

Outcome：

Human body magnetic induction measurement

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

中医五脏健康量表

指标类型：

次要指标

Outcome：

Traditional Chinese Medicine Five Zang-Organs Health Scale

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

中医湿证量表

指标类型：

次要指标

Outcome：

Traditional Chinese Medicine Dampness Syndrome Scale

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

中医虚实量表

指标类型：

次要指标

Outcome：

Traditional Chinese Medicine Deficiency-Excess Scale

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

改良弗明汉卒中量表

指标类型：

次要指标

Outcome：

The Modified Framingham Stroke Risk Profile

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：

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：

正在进行

Recruiting

年龄范围：

最小 18 岁
Min age years
最大 80 岁
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）：

不需要随机

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

be unnecessary

盲法：

Blinding：

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）：

不公开

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

no

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：

病例报告表的填写与移交 监察员作为申办方的指派代表，有权监查试验的进行是否遵循实验方案。病例报告表（CRF）由研究者填写，并做到数据的载入及时、完整、清晰和准确，且与原始资料一致。监察员对CRF进行核查，如有错误和遗漏，应及时要求研究真更正，并在更正处签名和注明日期且保持原有记录清晰可见。 CRF表经监察员核查无误后签字，将报告表移交临床试验数据管理员，进行数据录入与管理工作。对于完成的病例报告表在研究者、监查员、数据管理员之间的传送应有专门的记录，收到时应有相应的签名，记录妥善保存。 数据的录入与修改 数据录入与管理由科室数据管理员负责。数据管理员在数据录入前需再次对CRF表进行核查，产生疑问时，以疑问解答表（DRQ）的形式通过临床监查员向研究者发出询问，研究者应尽快做出回答并返回。DRQ应需妥善保存。 数据管理员录入数据采用双份录入，相互核查原则。录入过程发现问题或意外情况，应做好登记并及时报告。并与主要研究者一起，按病例报告表中各指标数值的范围和相互关系拟定数据范围检查和逻辑检查内容。并编写相应的计算机程序，在输入前控制错误数据输入，如发现问题，必要时可再次发出DRQ。 原始CRF再按照要求完成数据录入和核查后，按编号的顺序归档保存，并填有检索目录等，以备查考。电子数据文件包括数据库、检查程序、分析程序、分析结果、编码本和说明文件等，应分类保存，并有多个备份保存于不同磁盘或记录介质上，妥善保存，防止损坏。所有原始档案应按《药物临床试验质量管理规范》的规定保存。

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

Filling and Transfer of Case Report Forms The monitor as the assigned representative of the sponsor has the right to monitor whether the trial is conducted in accordance with the experimental protocol. The Case Report Form (CRF) is filled out by the investigator ensuring that the data entry is timely complete clear and accurate and consistent with the original data. The monitor verifies the CRF. In case of errors or omissions the investigator should be promptly requested to make corrections. The monitor should sign and date at the correction site while keeping the original record clearly visible. After the CRF has been verified as correct by the monitor and signed the report form will be transferred to the clinical trial data manager for data entry and management. There should be specific records for the transmission of completed CRF among investigators monitors and data managers. Corresponding signatures should be obtained upon receipt and the records should be properly preserved. Data Entry and Modification Data entry and management are the responsibilities of the departmental data manager. Before data entry the data manager needs to verify the CRF again. When in doubt inquiries will be sent to the investigator in the form of a Data Resolution Questionnaire (DRQ) through the clinical monitor. The investigator should respond as soon as possible and return it. The DRQ should be properly preserved. The data manager adopts the principle of double data entry and mutual verification for data entry. In case of problems or unexpected situations during the entry process records should be made and reported promptly. Together with the principal investigator the data manager should formulate the content of data range check and logical check according to the ranges and interrelationships of the values of various indicators in the CRF. Corresponding computer programs should be written to control the input of incorrect data before input. If problems are found DRQ can be issued again if necessary. After the original CRF has completed data entry and verification as required it should be archived and preserved in numerical order with a retrieval catalogue filled in for future reference. Electronic data files including databases check programs analysis programs analysis results codebooks and instruction documents should be classified and preserved with multiple backups saved on different disks or recording media and properly preserved to prevent damage. All original archives should be preserved in accordance with the provisions of the Good Clinical Practice.

数据管理委员会：

Data Managemen Committee：

有

Yes

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):

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