A Multi-center Study on Artificial Intelligence-Based Quantitative Evaluation of Echocardiography

NCT ID: NCT07133516

Last Updated: 2025-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-22

Study Completion Date

2026-07-31

Brief Summary

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This project aims to collaborate with multiple medical institutions to verify the accuracy, stability, and clinical application value of AI algorithms in echocardiographic quantitative measurement through multi-center clinical research. Specific objectives include:

1. Compare the automatic measurement results of AI with the manual measurement data from physicians of different levels, and analyze the measurement deviation and consistency of AI in key parameters such as intracardiac diameter, volume, and function.
2. Investigate whether AI-assisted measurement can significantly reduce echocardiogram analysis time and optimize clinical workflows. Through multi-center data validation, establish a standardized reference system for AI ultrasound measurement, promote the promotion and application of AI technology in medical institutions at all levels, and reduce diagnostic differences between different hospitals and physicians.
3. Exploring the application of AI in special cases: Assessing the measurement stability of AI algorithms in complex cases (such as cardiomyopathy, valvular disease, coronary heart disease, etc.), and optimizing AI models to meet broader clinical needs.

Detailed Description

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Cardiovascular disease is a major threat to the health of Chinese residents, and echocardiography, as its core diagnostic tool, directly affects clinical decision-making in terms of measurement accuracy and efficiency. However, traditional ultrasound evaluation heavily relies on physician experience, with pain points such as strong subjectivity, time-consuming measurements, and uneven levels of primary diagnosis. There is an urgent need for technological innovation to improve diagnostic standardization. In recent years, artificial intelligence (AI) technology has shown great potential in the field of medical image analysis, which can achieve automated quantitative measurement of cardiac chamber structure and function. However, existing AI models generally have problems such as insufficient multi center validation and limited adaptability to complex cases, which restrict their clinical translation and application.

To overcome these bottlenecks, this project collaborates with multiple medical institutions to conduct clinical research, systematically evaluating the measurement differences between AI algorithms and physicians of different levels, and assessing the accuracy and stability of AI algorithms. The research will focus on verifying the value of AI technology in improving diagnostic consistency, optimizing workflows, and exploring its potential applications in complex cardiovascular diseases. By establishing a standardized evaluation system, this project aims to promote the standardized application of AI ultrasound technology, ultimately achieving the goal of improving diagnosis and treatment efficiency, promoting the sinking of high-quality medical resources, and helping to improve the overall level of cardiovascular disease prevention and treatment.

Conditions

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Artificial Intelligence (AI) Artificial Intelligence (AI) in Diagnosis Cardiovascular Diseases (CVD) Echocardiography

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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AI group

The cardiac chamber size and functional parameters of all 1600 subjects were measured by AI

No interventions assigned to this group

Senior physician group

The cardiac chamber size and functional parameters of all 1600 subjects were measured by senior physicians at the PI unit

No interventions assigned to this group

Intermediate physician group

The cardiac chamber size and functional parameters of all 1600 subjects were measured by intermediate physicians at each sub center

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Age ≥18 - 80 years;
2. Types of diseases (8 in total, 200 cases each):

1. Normal heart
2. Coronary heart disease (with segmental thinning and abnormal movement)
3. Valve disease (valve stenosis or reflux)
4. Hypertensive heart disease
5. Atrial fibrillation
6. Heart failure
7. Dilated cardiomyopathy
8. Hypertrophic cardiomyopathy

Exclusion Criteria

1. Patients with congenital heart disease
2. Patients with poor image quality
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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First Hospital of China Medical University

OTHER

Sponsor Role lead

Responsible Party

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Chunyan Ma

Chief of Cardiovascular Ultrasound

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Huainan First People's Hospital

Huainan, Anhui, China

Site Status RECRUITING

Union Hospital Affiliated to Fujian Medical University

Fuzhou, Fujian, China

Site Status RECRUITING

Meizhou People's Hospital

Meizhou, Guangdong, China

Site Status RECRUITING

Shantou Central Hospital

Shantou, Guangdong, China

Site Status RECRUITING

Shenzhen Hospital of Fuwai Hospital

Shenzhen, Guangdong, China

Site Status RECRUITING

Shenzhen People's Hospital

Shenzhen, Guangdong, China

Site Status RECRUITING

Affiliated Hospital of Youjiang Medical University for Nationalities

Baise City, Guangxi, China

Site Status RECRUITING

Guilin Hospital of Traditional Chinese Medicine

Guilin, Guangxi, China

Site Status RECRUITING

The Fourth Affiliated Hospital of Guangxi Medical University / Liuzhou Workers' Hospital

Liuzhou, Guangxi, China

Site Status RECRUITING

Yulin First People's Hospital

Yulin, Guangxi, China

Site Status RECRUITING

The Second Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China

Site Status RECRUITING

Haikou People's Hospital

Haikou, Hainan, China

Site Status RECRUITING

The Second Affiliated Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status RECRUITING

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status RECRUITING

Loudi First People's Hospital

Loudi, Hunan, China

Site Status RECRUITING

Hunan Province Directly Affiliated TCM Hospital

Zhuzhou, Hunan, China

Site Status RECRUITING

Baotou No.4 Hospital

Baotou, Inner Mongolia, China

Site Status RECRUITING

Shangrao Central Hospital

Shangrao, Jiangxi, China

Site Status RECRUITING

Shangrao People's Hospital

Shangrao, Jiangxi, China

Site Status RECRUITING

Ansteel Group General Hospital

Anshan, Liaoning, China

Site Status RECRUITING

Chaoyang Central Hospital

Chaoyang, Liaoning, China

Site Status RECRUITING

Fushun Central Hospital

Fushun, Liaoning, China

Site Status RECRUITING

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Site Status RECRUITING

The First Hospital of China Medical University

Shenyang, Liaoning, China

Site Status RECRUITING

Qinghai Provincial Hospital of Cardiovascular and Cerebrovascular Diseases

Xining, Qinghai, China

Site Status RECRUITING

The Central Hospital Affiliated to Shandong First Medical University

Tai’an, Shandong, China

Site Status RECRUITING

Linfen People's Hospital

Linfen, Shanxi, China

Site Status RECRUITING

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

Site Status RECRUITING

Jiangyou 903 Hospital

Jiangyou, Sichuan, China

Site Status RECRUITING

Bishan Hospital Affiliated to Chongqing Medical University

Chongqing, , China

Site Status RECRUITING

Bishan Hospital Affiliated to Chongqing University of Chinese Medicine (Chongqing Bishan District Hospital of Traditional Chinese Medicine)

Chongqing, , China

Site Status RECRUITING

Chongqing Hospital of Traditional Chinese Medicine

Chongqing, , China

Site Status RECRUITING

Chongqing People's Hospital

Chongqing, , China

Site Status RECRUITING

Fuling Hospital Affiliated to Chongqing University

Chongqing, , China

Site Status RECRUITING

The First Affiliated Hospital of Army Medical University

Chongqing, , China

Site Status RECRUITING

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, , China

Site Status RECRUITING

Shanghai Changzheng Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chunyan Ma the First Hospital of China Medical Univeristy, Ph.D

Role: CONTACT

13998816448

Facility Contacts

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Binghui Duan

Role: primary

Jinguo Li

Role: primary

Youhong Zhang

Role: primary

Liangyu Wang

Role: primary

Yong Jiang

Role: primary

Yingying Liu

Role: primary

Chengcai Chen

Role: primary

Mingyue Wu

Role: primary

Bo Hu

Role: primary

Hongxia Yin

Role: primary

Wei Zeng

Role: primary

Zelai Mo

Role: primary

Hongning Yin

Role: primary

Mingxing Xie

Role: primary

Weiqun Yin

Role: primary

Yibo Zhang

Role: primary

Yan Jing

Role: primary

Dongdong Huang

Role: primary

Shunping Qiu

Role: primary

Ying Liu

Role: primary

Hong Zhou

Role: primary

Wei Wang

Role: primary

Weidong Ren

Role: primary

Chunyan Ma

Role: primary

Renbo Jin

Role: primary

Lihua Jin

Role: primary

Liyan Guo

Role: primary

Qi Zhou

Role: primary

Juanjuan Wu

Role: primary

Min Lu

Role: primary

Xiaoli Zhang

Role: primary

Yang Yang

Role: primary

Shigen Zhong

Role: primary

Zhirong He

Role: primary

Yanli Guo

Role: primary

Haitao Ran

Role: primary

Chun Liang

Role: primary

Other Identifiers

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MAIQUEE STUDY

Identifier Type: -

Identifier Source: org_study_id

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