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：	ChiCTR2400082362
最近更新日期： Date of Last Refreshed on：	2024-03-27 13:03:25
注册时间： Date of Registration：	2024-03-27 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	阻塞性冠心病“观舌望脉”多模态诊断模型的构建与评价
Public title：	Construction and evaluation of a multimodal diagnostic model for obstructive coronary heart disease using tongue observation and pulse monitoring
注册题目简写：
English Acronym：
研究课题的正式科学名称：	阻塞性冠心病“观舌望脉”多模态诊断模型的构建与评价
Scientific title：	Construction and evaluation of a multimodal diagnostic model for obstructive coronary heart disease using tongue observation and pulse monitoring
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：	杨珺涵	研究负责人：	张哲
Applicant：	Yang Junhan	Study leader：	Zhang Zhe
申请注册联系人电话： Applicant telephone：	+86 151 4199 8882	研究负责人电话： Study leader's telephone：	+86 181 0245 9155
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：	996920424@qq.com	研究负责人电子邮件： Study leader's E-mail：	pedtrainzhzh7676@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：	辽宁省沈阳市皇姑区崇山东路79号	研究负责人通讯地址：	辽宁省沈阳市皇姑区崇山东路79号
Applicant address：	No. 79 Chongshan East Road, Huanggu District, Shenyang City, Liaoning Province	Study leader's address：	No. 79 Chongshan East Road, Huanggu District, Shenyang City, Liaoning 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：	辽宁中医药大学
Applicant's institution：	Liaoning University Of Traditional Chinese Medicine
研究负责人所在单位：	辽宁中医药大学附属医院
Affiliation of the Leader：	No. 33 Beiling Street, Huanggu District, Shenyang City, Liaoning Province

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：	2023059CS(KT)-024-01	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：	辽宁中医药大学附属医院伦理委员会
Name of the ethic committee：	Ethics Committee of Liaoning University of Traditional Chinese Medicine Affiliated Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2023-11-30 00:00:00
伦理委员会联系人：	李晓
Contact Name of the ethic committee：	Li Xiao
伦理委员会联系地址：	辽宁省沈阳市皇姑区北陵大街33号
Contact Address of the ethic committee：	No. 33 Beiling Street, Huanggu District, Shenyang City, Liaoning Province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 24 8296 1989	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：

辽宁中医药大学附属医院

Primary sponsor：

Liaoning University of Traditional Chinese Medicine Affiliated Hospital

研究实施负责（组长）单位地址：

辽宁省沈阳市皇姑区北陵大街33号

Primary sponsor's address：

No. 33 Beiling Street, Huanggu District, Shenyang City, Liaoning 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)：	辽宁	市(区县)：
Country：	China	Province：	Liaoning	City：
单位(医院)：	辽宁中医药大学附属医院	具体地址：	辽宁省沈阳市皇姑区北陵大街33号
Institution hospital：	Liaoning University of Traditional Chinese Medicine Affiliated Hospital	Address：	No. 33 Beiling Street, Huanggu District, Shenyang City, Liaoning Province

经费或物资来源：

国家中医药管理局首批青年岐黄学者支持项目（国中医药人教函[2020]218号）

Source(s) of funding：

The First Batch of Young Qi Huang Scholars Support Project of the State Administration of Traditional Chinese Medicine (Guozhongyao Renjiao Letter [2020] No. 218)

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：

诊断试验

Study type：

Diagnostic test

研究所处阶段：

其它

Study phase：

N/A

研究设计：

诊断试验诊断准确性

Study design：

Diagnostic test for accuracy

研究目的：

构建基于舌诊、脉诊、问诊的阻塞性冠心病各诊断模型及其多模态模型，评估各模型性能，运用人工智能算法结合中医特色诊法，开发无创、便捷、高效的阻塞性冠心病新型诊断方法。

Objectives of Study：

Construct various diagnostic models and multimodal models for obstructive coronary heart disease based on tongue diagnosis, pulse diagnosis, and consultation, evaluate the performance of each model, and use artificial intelligence algorithms combined with traditional Chinese medicine characteristic diagnostic methods to develop a non-invasive, convenient, and efficient new diagnostic method for obstructive coronary heart disease.

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的患者。 ②合并重度心律失常伴有血流动力学改变的患者、脑血管病急性和亚急性期的患者、慢性阻塞性肺疾病急性加重期、肺心病或呼吸衰竭患者、合并造血系统或恶心肿瘤的严重原发性疾病的患者。 ③精神疾病患者、孕期或哺乳期妇女。 ④拒不配合脉搏波等资料采集者或不能伸舌者。

Exclusion criteria：

① Patients with infection, fever, trauma, burn, operation history or active tuberculosis in the last week. ② Patients with severe arrhythmia accompanied by hemodynamic changes, patients with acute and subacute stages of cerebrovascular disease, patients with acute exacerbation of chronic obstructive pulmonary disease, pulmonary heart disease or respiratory failure, and patients with severe primary diseases complicated by hematopoietic system or nausea tumors. ③ Mental illness patients, pregnant or lactating women. ④ Refuse those who are not compatible with pulse wave data collection or those who cannot extend their tongue.

研究实施时间：

Study execute time：

从 From 2024-03-15 00:00:00至 To 2025-06-30 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2024-04-15 00:00:00 至 To 2024-12-31 00:00:00

诊断试验：

Diagnostic Tests：

金标准或参考标准（即可准确诊断某疾病的单项方法或多项联合方法，在本研究中用于诊断是否有该病的临床参考标准）：	采用冠状动脉造影结果作为金标准。
Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):	Using coronary angiography results as the gold standard. Diagnostic criteria for obstructive coronary heart disease: Coronary angiography is performed to determine the presence of at least one coronary artery with a diameter stenosis degree of ≥ 75%, or the left main artery with a diameter stenosis degree of>50%.
指标试验（即本研究的待评估诊断试验，无论为方法、生物标志物或设备，均请列出名称）：	基于舌诊、脉诊、问诊的阻塞性冠心病机器学习多模态诊断模型的性能
Index test:	A Machine Learning Multimodal Diagnosis Model for Obstructive Coronary Heart Disease Based on Tongue Diagnosis, Pulse Diagnosis, and Consultation
目标人群（可以是某种疾病患者或正常人群，详细描述其疾病特征，注意应纳入符合分布特点的全序列病例，具有良好的代表性）	门诊以冠状动脉粥样硬化性心脏病为主诊断收入院的患者，行冠状动脉造影判定至少存在一支冠状动脉的直径狭窄程度≥75%，或左主干直径狭窄程度>50%的阻塞性冠心病者为目标人群。冠心病心绞痛以发作性胸痛为主要临床表现，疼痛的特点为：1.部位：主要在胸骨体之后，可波及心前区，有手掌大小范围，甚至横贯前胸，界限不很清楚。常放射至左肩、左臂内侧达无名指和小指，或至颈、咽或下颌部。 2.性质：胸痛常为压迫、发闷或紧缩性，也可有烧灼感，但不像针刺或刀扎样锐性痛，偶伴濒死的恐惧感觉。有些患者仅觉胸闷不适而非胸痛。发作时，患者往往被迫停止正在进行的活动，直至症状缓解。 3.诱因：发作常由体力劳动或情绪激动（如愤怒、焦急、过度兴奋等）所诱发，饱食、寒冷、吸烟、心动过速、休克等亦可诱发。疼痛多发生于劳力或激动的当时，而不是在劳累之后。典型的心绞痛常在相似的条件下重复发生，但有时同样的劳力只在早晨而不在下午引起心绞痛，提示与晨间交感神经兴奋性增高等昼夜节律变化有关。 4.持续时间：疼痛出现后常逐步加重，达到一定程度后持续一段时间，然后逐渐消失，心绞痛一般持续数分钟至十余分钟。	例数: Sample size: 334
Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):	Outpatients admitted to the hospital mainly diagnosed as coronary atherosclerotic heart disease, who were diagnosed as having obstructive coronary heart disease with at least one coronary artery diameter stenosis ≥ 75% or left main artery diameter stenosis>50% by coronary angiography, were the target population. Coronary heart disease and angina pectoris are mainly characterized by paroxysmal chest pain. The pain is characterized by: 1. Location: mainly behind the sternum, which can affect the precordial area, ranging in size from the palm to the transverse chest, with unclear boundaries. It often radiates to the left shoulder and inner side of the left arm, reaching the ring and little fingers, or to the neck, pharynx, or lower jaw. 2. Nature: Chest pain is often characterized by compression, tightness, or tightness, and may also have a burning sensation, but it is not as sharp as needle or knife piercing pain, and occasionally accompanied by a feeling of impending death. Some patients only feel chest tightness and discomfort rather than chest pain. During an attack, patients are often forced to stop ongoing activities until symptoms are relieved. 3. Inducing factors: Episodes are often induced by physical labor or emotional excitement (such as anger, anxiety, excessive excitement, etc.), and can also be triggered by satiety, cold, smoking, tachycardia, shock, etc. Pain often occurs during exertion or excitement, rather than after exhaustion. Typical angina often occurs repeatedly under similar conditions, but sometimes the same amount of labor only causes angina in the morning and not in the afternoon, indicating a correlation with circadian rhythm changes such as increased excitability of the sympathetic nervous system in the morning. 4. Duration: Pain often worsens gradually after it appears, lasts for a certain period of time, and then gradually disappears. Angina pectoris usually lasts for several minutes to more than ten minutes.
容易混淆的疾病人群（即与目标疾病不易区分的一种或多种不同疾病，应避免采用正常人群对照的病例-对照设计）：	同样门诊以冠状动脉粥样硬化性心脏病为主诊断收入院的患者，行冠状动脉造影判定所有冠状动脉的直径狭窄程度均＜50%，但是仍然具有类似心绞痛症状者为非阻塞性冠心病患者，为易混淆人群。	例数: Sample size: 334
Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:	Outpatients admitted to the hospital mainly diagnosed as coronary atherosclerotic heart diseasewho underwent coronary angiography to determine that the diameter stenosis degree of all coronary arteries was less than 50%, but those who still had symptoms similar to angina pectoris were non obstructive coronary heart disease patients, which was easily confused.

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	辽宁	市(区县)：
Country：	China	Province：	Liaoning	City：
单位(医院)：	辽宁中医药大学附属医院	单位级别：	三甲
Institution hospital：	Liaoning University of Traditional Chinese Medicine Affiliated Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	AUC值	指标类型：	主要指标
Outcome：	AUC value	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	灵敏度	指标类型：	主要指标
Outcome：	sensitivity	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	特异度	指标类型：	主要指标
Outcome：	Specificity	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	假阳性率	指标类型：	主要指标
Outcome：	False positive rate	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	假阴性率	指标类型：	主要指标
Outcome：	False negative rate	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	准确度	指标类型：	主要指标
Outcome：	Accuracy	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	预测值	指标类型：	次要指标
Outcome：	Predictive value	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	似然比	指标类型：	次要指标
Outcome：	Likehood ratio	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	FI分数	指标类型：	次要指标
Outcome：	FI score	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：	无	组织：
Sample Name：	None	Tissue：
人体标本去向	其它	说明
Fate of sample：	0thers	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	岁 years
最大 Max age	85	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）：

无

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）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

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）：	ResMan临床试验公共管理平台http://www.medresman.org.cn/
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	ResMan Research Manager http://www.medresman.org.cn/
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：	采用病例记录表进行数据采集
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Case record forms were used for data collection
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：	2024-03-27 13:03:19