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Recruiting Observational

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

NCT07133516 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2025-07-22
Last updated
2025-08-21

Condition(s) studied

Artificial Intelligence (AI)Artificial Intelligence (AI) in DiagnosisCardiovascular Diseases (CVD)Echocardiography

Study 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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • 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) — Artificial intelligence and intermediate doctors measurement results of each sub center will be completed within one day after data collection. Senior physicians measurement results of PI unit will be completed within one month after data collection.
    Left ventricular end diastolic volume (EDV, ml), end systolic volume (ESV, ml), and ejection fraction (EF, %) (calculated by (EDV-ESV)/EDV\*100% ) in the four chamber view and two chamber view, as well as the Simpson biplane left ventricular volume (ml) and ejection fraction (%) results.
  • 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) — Artificial intelligence and intermediate doctors measurement results of each sub center will be completed within one day after data collection. Senior physicians measurement results of PI unit will be completed within one month after data collection.
    Right ventricular area change rate calculated by (EDA-ESA)/EDA\*100%.
  • 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) — Artificial intelligence and intermediate doctors measurement results of each sub center will be completed within one day after data collection. Senior physicians measurement results of PI unit will be completed within one month after data collection.
    Right ventricular end diastolic area (EDA) and end systolic area (ESA).

Trial sites (37)

FacilityCityRegionStatus
Huainan First People's Hospital Huainan Anhui Recruiting
Union Hospital Affiliated to Fujian Medical University Fuzhou Fujian Recruiting
Meizhou People's Hospital Meizhou Guangdong Recruiting
Shantou Central Hospital Shantou Guangdong Recruiting
Shenzhen Hospital of Fuwai Hospital Shenzhen Guangdong Recruiting
Shenzhen People's Hospital Shenzhen Guangdong Recruiting
Affiliated Hospital of Youjiang Medical University for Nationalities Baise City Guangxi Recruiting
Guilin Hospital of Traditional Chinese Medicine Guilin Guangxi Recruiting
The Fourth Affiliated Hospital of Guangxi Medical University / Liuzhou Workers' Hospital Liuzhou Guangxi Recruiting
Yulin First People's Hospital Yulin Guangxi Recruiting
The Second Affiliated Hospital of Zunyi Medical University Zunyi Guizhou Recruiting
Haikou People's Hospital Haikou Hainan Recruiting
The Second Affiliated Hospital of Hebei Medical University Shijiazhuang Hebei Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei Recruiting
Loudi First People's Hospital Loudi Hunan Recruiting
Hunan Province Directly Affiliated TCM Hospital Zhuzhou Hunan Recruiting
Baotou No.4 Hospital Baotou Inner Mongolia Recruiting
Shangrao Central Hospital Shangrao Jiangxi Recruiting
Shangrao People's Hospital Shangrao Jiangxi Recruiting
Ansteel Group General Hospital Anshan Liaoning Recruiting
Chaoyang Central Hospital Chaoyang Liaoning Recruiting
Fushun Central Hospital Fushun Liaoning Recruiting
Shengjing Hospital of China Medical University Shenyang Liaoning Recruiting
The First Hospital of China Medical University Shenyang Liaoning Recruiting
Qinghai Provincial Hospital of Cardiovascular and Cerebrovascular Diseases Xining Qinghai Recruiting
The Central Hospital Affiliated to Shandong First Medical University Tai’an Shandong Recruiting
Linfen People's Hospital Linfen Shanxi Recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University Xi’an Shanxi Recruiting
Jiangyou 903 Hospital Jiangyou Sichuan Recruiting
Bishan Hospital Affiliated to Chongqing Medical University Chongqing China Recruiting
Bishan Hospital Affiliated to Chongqing University of Chinese Medicine (Chongqing Bishan District Hospital of Traditional Chinese Medicine) Chongqing China Recruiting
Chongqing Hospital of Traditional Chinese Medicine Chongqing China Recruiting
Chongqing People's Hospital Chongqing China Recruiting
Fuling Hospital Affiliated to Chongqing University Chongqing China Recruiting
The First Affiliated Hospital of Army Medical University Chongqing China Recruiting
The Second Affiliated Hospital of Chongqing Medical University Chongqing China Recruiting
Shanghai Changzheng Hospital Shanghai China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07133516 on ClinicalTrials.gov ↗ ← All trials in China