About this trial
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
This trial accepts healthy volunteersQualifiers
Age ≥18 - 80 years;
Normal heart
Coronary heart disease (with segmental thinning and abnormal movement)
Valve disease (valve stenosis or reflux)
Disqualifiers
Patients with congenital heart disease
Patients with poor image quality
Trial population
Patients who require cardiac ultrasound examination for various reasons in clinical practice. Ultrasound and clinical diagnosis of patients with normal cardiac structure and function, as well as those with coronary heart disease, valve disease, hypertensive heart disease, atrial fibrillation, heart failure, dilated cardiomyopathy, and hypertrophic cardiomyopathy. A total of 1600 adults were enrolled in multiple centers;
Trial design
Case-control
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary 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)
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)
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)
Right ventricular end diastolic area (EDA) and end systolic area (ESA).
Secondary outcomes
Doppler ultrasound measurement indicators by 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)
Forward blood flow velocity of mitral and tricuspid valve (m/s).
Mitral valve annulus and tricuspid valve annulus displacement 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)
Mitral valve annulus and tricuspid valve annulus displacement (mm)
Sponsors and contacts
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