NCT07133516

Brief 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. 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. 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,600

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Jul 2025

Shorter than P25 for all trials

Geographic Reach
1 country

37 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Jul 2025Jul 2026

Study Start

First participant enrolled

July 22, 2025

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 21, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

August 21, 2025

Status Verified

August 1, 2025

Enrollment Period

11 months

First QC Date

July 30, 2025

Last Update Submit

August 18, 2025

Conditions

Keywords

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

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

  • 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%.

    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.

  • 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).

    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 (2)

  • 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)

    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.

  • 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)

    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.

Study Arms (3)

AI group

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

Senior physician group

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

Intermediate physician group

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study 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;

You may qualify if:

  • Age ≥18 - 80 years;
  • Types of diseases (8 in total, 200 cases each):
  • Normal heart
  • Coronary heart disease (with segmental thinning and abnormal movement)
  • Valve disease (valve stenosis or reflux)
  • Hypertensive heart disease
  • Atrial fibrillation
  • Heart failure
  • Dilated cardiomyopathy
  • Hypertrophic cardiomyopathy

You may not qualify if:

  • Patients with congenital heart disease
  • Patients with poor image quality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (37)

Huainan First People's Hospital

Huainan, Anhui, China

RECRUITING

Union Hospital Affiliated to Fujian Medical University

Fuzhou, Fujian, China

RECRUITING

Meizhou People's Hospital

Meizhou, Guangdong, China

RECRUITING

Shantou Central Hospital

Shantou, Guangdong, China

RECRUITING

Shenzhen Hospital of Fuwai Hospital

Shenzhen, Guangdong, China

RECRUITING

Shenzhen People's Hospital

Shenzhen, Guangdong, China

RECRUITING

Affiliated Hospital of Youjiang Medical University for Nationalities

Baise City, Guangxi, China

RECRUITING

Guilin Hospital of Traditional Chinese Medicine

Guilin, Guangxi, China

RECRUITING

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

Liuchow, Guangxi, China

RECRUITING

Yulin First People's Hospital

Yulin, Guangxi, China

RECRUITING

The Second Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China

RECRUITING

Haikou People's Hospital

Haikou, Hainan, China

RECRUITING

The Second Affiliated Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

RECRUITING

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

Wuhan, Hubei, China

RECRUITING

Loudi First People's Hospital

Loudi, Hunan, China

RECRUITING

Hunan Province Directly Affiliated TCM Hospital

Zhuzhou, Hunan, China

RECRUITING

Baotou No.4 Hospital

Baotou, Inner Mongolia, China

RECRUITING

Shangrao Central Hospital

Shangrao, Jiangxi, China

RECRUITING

Shangrao People's Hospital

Shangrao, Jiangxi, China

RECRUITING

Ansteel Group General Hospital

Anshan, Liaoning, China

RECRUITING

Chaoyang Central Hospital

Chaoyang, Liaoning, China

RECRUITING

Fushun Central Hospital

Fushun, Liaoning, China

RECRUITING

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

RECRUITING

The First Hospital of China Medical University

Shenyang, Liaoning, China

RECRUITING

Qinghai Provincial Hospital of Cardiovascular and Cerebrovascular Diseases

Xining, Qinghai, China

RECRUITING

The Central Hospital Affiliated to Shandong First Medical University

Tai’an, Shandong, China

RECRUITING

Linfen People's Hospital

Linfen, Shanxi, China

RECRUITING

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

RECRUITING

Jiangyou 903 Hospital

Jiangyou, Sichuan, China

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

MeSH Terms

Conditions

Cardiovascular Diseases

Central Study Contacts

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

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Cardiovascular Ultrasound

Study Record Dates

First Submitted

July 30, 2025

First Posted

August 21, 2025

Study Start

July 22, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

August 21, 2025

Record last verified: 2025-08

Locations