A Multi-center Study on Artificial Intelligence-Based Quantitative Evaluation of Echocardiography
Trial ID: NCT07133516
Status: RECRUITING
Study type: OBSERVATIONAL
Start date: 2025-07-22
Completion date: 2026-07-31
Sponsor: First Hospital of China Medical University
Conditions: Artificial Intelligence (AI); Artificial Intelligence (AI) in Diagnosis; Cardiovascular Diseases (CVD); Echocardiography
Locations: Huainan First People's Hospital; Union Hospital Affiliated to Fujian Medical University; Meizhou People's Hospital; Shantou Central Hospital; Shenzhen Hospital of Fuwai Hospital; Shenzhen People's Hospital; Affiliated Hospital of Youjiang Medical University for Nationalities; Guilin Hospital of Traditional Chinese Medicine; The Fourth Affiliated Hospital of Guangxi Medical University / Liuzhou Workers' Hospital; Yulin First People's Hospital; The Second Affiliated Hospital of Zunyi Medical University; Haikou People's Hospital; The Second Affiliated Hospital of Hebei Medical University; Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; Loudi First People's Hospital; Hunan Province Directly Affiliated TCM Hospital; Baotou No.4 Hospital; Shangrao Central Hospital; Shangrao People's Hospital; Ansteel Group General Hospital; Chaoyang Central Hospital; Fushun Central Hospital; Shengjing Hospital of China Medical University; The First Hospital of China Medical University; Qinghai Provincial Hospital of Cardiovascular and Cerebrovascular Diseases; The Central Hospital Affiliated to Shandong First Medical University; Linfen People's Hospital; The Second Affiliated Hospital of Xi'an Jiaotong University; Jiangyou 903 Hospital; Bishan Hospital Affiliated to Chongqing Medical University; Bishan Hospital Affiliated to Chongqing University of Chinese Medicine (Chongqing Bishan District Hospital of Traditional Chinese Medicine); Chongqing Hospital of Traditional Chinese Medicine; Chongqing People's Hospital; Fuling Hospital Affiliated to Chongqing University; The First Affiliated Hospital of Army Medical University; The Second Affiliated Hospital of Chongqing Medical University; Shanghai Changzheng Hospital
Countries: China; China; China; China; China; China; China; China; China; China; China; China; China; China; China; China; China; China; China; China; China; China; China; China; China; China; China; China; China; China; China; China; China; China; China; China; China
Enrollment: 1600
Age range: 18 Years - 80 Years
Sex: ALL

Summary:
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.

Eligibility criteria:
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

Outcomes:
The indicators of left ventricular size and function are measured by AI, senior physicians at the PI unit, and intermediate physicians at each sub center respectively (all parameters are measured by Mindray ultrasonic machines on the machine); The indicator of right ventricular function is measured by AI, senior physicians at the PI unit, and intermediate physicians at each sub center respectively (all parameters are measured by Mindray ultrasonic machines on the machine); The indicators of right ventricular size are measured by AI, senior physicians at the PI unit, and intermediate physicians at each sub center respectively (all parameters are measured by Mindray ultrasonic machines on the machine)