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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorFirst Hospital of China Medical University

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,600 Participants
are grouped into 3 trial groups
Group A: AI group
Group B: Senior physician group
Group C: Intermediate physician group

Trial outcomes

Primary outcomes

1

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.

Time frame
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.
2

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%.

Time frame
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.
3

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).

Time frame
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.

Secondary outcomes

1

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).

Time frame
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.
2

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)

Time frame
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.

Other outcomes

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