Ignite Creation Date:
2025-12-26 @ 11:50 AM
Ignite Modification Date:
2025-12-26 @ 11:50 AM
Study NCT ID:
NCT07133516
Status:
RECRUITING
Last Update Posted:
2025-08-21
First Post:
2025-07-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Multi-center Study on Artificial Intelligence-Based Quantitative Evaluation of Echocardiography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-18', 'studyFirstSubmitDate': '2025-07-30', 'studyFirstSubmitQcDate': '2025-08-18', 'lastUpdatePostDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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)', 'timeFrame': '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.', 'description': '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.'}, {'measure': '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)', 'timeFrame': '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.', 'description': 'Right ventricular area change rate calculated by (EDA-ESA)/EDA\\*100%.'}, {'measure': '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)', 'timeFrame': '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.', 'description': 'Right ventricular end diastolic area (EDA) and end systolic area (ESA).'}], 'secondaryOutcomes': [{'measure': '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)', 'timeFrame': '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.', 'description': 'Forward blood flow velocity of mitral and tricuspid valve (m/s).'}, {'measure': '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)', 'timeFrame': '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.', 'description': 'Mitral valve annulus and tricuspid valve annulus displacement (mm)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Artificial Intelligence (AI)', 'Artificial Intelligence (AI) in Diagnosis', 'Cardiovascular Diseases (CVD)', 'Echocardiography'], 'conditions': ['Artificial Intelligence (AI)', 'Artificial Intelligence (AI) in Diagnosis', 'Cardiovascular Diseases (CVD)', 'Echocardiography']}, 'descriptionModule': {'briefSummary': '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:\n\n1. 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.\n2. 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.\n3. 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.', 'detailedDescription': 'Cardiovascular disease is a major threat to the health of Chinese residents, and echocardiography, as its core diagnostic tool, directly affects clinical decision-making in terms of measurement accuracy and efficiency. However, traditional ultrasound evaluation heavily relies on physician experience, with pain points such as strong subjectivity, time-consuming measurements, and uneven levels of primary diagnosis. There is an urgent need for technological innovation to improve diagnostic standardization. In recent years, artificial intelligence (AI) technology has shown great potential in the field of medical image analysis, which can achieve automated quantitative measurement of cardiac chamber structure and function. However, existing AI models generally have problems such as insufficient multi center validation and limited adaptability to complex cases, which restrict their clinical translation and application.\n\nTo overcome these bottlenecks, this project collaborates with multiple medical institutions to conduct clinical research, systematically evaluating the measurement differences between AI algorithms and physicians of different levels, and assessing the accuracy and stability of AI algorithms. The research will focus on verifying the value of AI technology in improving diagnostic consistency, optimizing workflows, and exploring its potential applications in complex cardiovascular diseases. By establishing a standardized evaluation system, this project aims to promote the standardized application of AI ultrasound technology, ultimately achieving the goal of improving diagnosis and treatment efficiency, promoting the sinking of high-quality medical resources, and helping to improve the overall level of cardiovascular disease prevention and treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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;', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 - 80 years;\n2. Types of diseases (8 in total, 200 cases each):\n\n 1. Normal heart\n 2. Coronary heart disease (with segmental thinning and abnormal movement)\n 3. Valve disease (valve stenosis or reflux)\n 4. Hypertensive heart disease\n 5. Atrial fibrillation\n 6. Heart failure\n 7. Dilated cardiomyopathy\n 8. Hypertrophic cardiomyopathy\n\nExclusion Criteria:\n\n1. Patients with congenital heart disease\n2. Patients with poor image quality'}, 'identificationModule': {'nctId': 'NCT07133516', 'acronym': 'MAIQUEE', 'briefTitle': 'A Multi-center Study on Artificial Intelligence-Based Quantitative Evaluation of Echocardiography', 'organization': {'class': 'OTHER', 'fullName': 'First Hospital of China Medical University'}, 'officialTitle': 'A Multi-center Study on Artificial Intelligence-Based Quantitative Evaluation of Echocardiography', 'orgStudyIdInfo': {'id': 'MAIQUEE STUDY'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AI group', 'description': 'The cardiac chamber size and functional parameters of all 1600 subjects were measured by AI'}, {'label': 'Senior physician group', 'description': 'The cardiac chamber size and functional parameters of all 1600 subjects were measured by senior physicians at the PI unit'}, {'label': 'Intermediate physician group', 'description': 'The cardiac chamber size and functional parameters of all 1600 subjects were measured by intermediate physicians at each sub center'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Huainan', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Binghui Duan', 'role': 'CONTACT'}], 'facility': "Huainan First People's Hospital", 'geoPoint': {'lat': 32.62639, 'lon': 116.99694}}, {'city': 'Fuzhou', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jinguo Li', 'role': 'CONTACT'}], 'facility': 'Union Hospital Affiliated to Fujian Medical University', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'city': 'Meizhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Youhong Zhang', 'role': 'CONTACT'}], 'facility': "Meizhou People's Hospital", 'geoPoint': {'lat': 24.28859, 'lon': 116.11768}}, {'city': 'Shantou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liangyu Wang', 'role': 'CONTACT'}], 'facility': 'Shantou Central Hospital', 'geoPoint': {'lat': 23.35489, 'lon': 116.67876}}, {'city': 'Shenzhen', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yong Jiang', 'role': 'CONTACT'}], 'facility': 'Shenzhen Hospital of Fuwai Hospital', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'city': 'Shenzhen', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yingying Liu', 'role': 'CONTACT'}], 'facility': "Shenzhen People's Hospital", 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'city': 'Baise City', 'state': 'Guangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chengcai Chen', 'role': 'CONTACT'}], 'facility': 'Affiliated Hospital of Youjiang Medical University for Nationalities', 'geoPoint': {'lat': 23.89013, 'lon': 106.62684}}, {'city': 'Guilin', 'state': 'Guangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Mingyue Wu', 'role': 'CONTACT'}], 'facility': 'Guilin Hospital of Traditional Chinese Medicine', 'geoPoint': {'lat': 25.28022, 'lon': 110.29639}}, {'city': 'Liuchow', 'state': 'Guangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bo Hu', 'role': 'CONTACT'}], 'facility': "The Fourth Affiliated Hospital of Guangxi Medical University / Liuzhou Workers' Hospital", 'geoPoint': {'lat': 24.32405, 'lon': 109.40698}}, {'city': 'Yulin', 'state': 'Guangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongxia Yin', 'role': 'CONTACT'}], 'facility': "Yulin First People's Hospital", 'geoPoint': {'lat': 22.6305, 'lon': 110.14686}}, {'city': 'Zunyi', 'state': 'Guizhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Zeng', 'role': 'CONTACT'}], 'facility': 'The Second Affiliated Hospital of Zunyi Medical University', 'geoPoint': {'lat': 27.68667, 'lon': 106.90722}}, {'city': 'Haikou', 'state': 'Hainan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zelai Mo', 'role': 'CONTACT'}], 'facility': "Haikou People's Hospital", 'geoPoint': {'lat': 20.03421, 'lon': 110.34651}}, {'city': 'Shijiazhuang', 'state': 'Hebei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongning Yin', 'role': 'CONTACT'}], 'facility': 'The Second Affiliated Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Mingxing Xie', 'role': 'CONTACT'}], 'facility': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Loudi', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weiqun Yin', 'role': 'CONTACT'}], 'facility': "Loudi First People's Hospital", 'geoPoint': {'lat': 27.73444, 'lon': 111.99444}}, {'city': 'Zhuzhou', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yibo Zhang', 'role': 'CONTACT'}], 'facility': 'Hunan Province Directly Affiliated TCM Hospital', 'geoPoint': {'lat': 27.83333, 'lon': 113.15}}, {'city': 'Baotou', 'state': 'Inner Mongolia', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yan Jing', 'role': 'CONTACT'}], 'facility': 'Baotou No.4 Hospital', 'geoPoint': {'lat': 40.6516, 'lon': 109.84389}}, {'city': 'Shangrao', 'state': 'Jiangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dongdong Huang', 'role': 'CONTACT'}], 'facility': 'Shangrao Central Hospital', 'geoPoint': {'lat': 28.45179, 'lon': 117.94287}}, {'city': 'Shangrao', 'state': 'Jiangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shunping Qiu', 'role': 'CONTACT'}], 'facility': "Shangrao People's Hospital", 'geoPoint': {'lat': 28.45179, 'lon': 117.94287}}, {'city': 'Anshan', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ying Liu', 'role': 'CONTACT'}], 'facility': 'Ansteel Group General Hospital', 'geoPoint': {'lat': 41.12361, 'lon': 122.99}}, {'city': 'Chaoyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hong Zhou', 'role': 'CONTACT'}], 'facility': 'Chaoyang Central Hospital', 'geoPoint': {'lat': 41.57028, 'lon': 120.45861}}, {'city': 'Fushun', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Wang', 'role': 'CONTACT'}], 'facility': 'Fushun Central Hospital', 'geoPoint': {'lat': 41.88669, 'lon': 123.94363}}, {'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weidong Ren', 'role': 'CONTACT'}], 'facility': 'Shengjing Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chunyan Ma', 'role': 'CONTACT'}], 'facility': 'The First Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Xining', 'state': 'Qinghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Renbo Jin', 'role': 'CONTACT'}], 'facility': 'Qinghai Provincial Hospital of Cardiovascular and Cerebrovascular Diseases', 'geoPoint': {'lat': 36.62554, 'lon': 101.75739}}, {'city': 'Tai’an', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lihua Jin', 'role': 'CONTACT'}], 'facility': 'The Central Hospital Affiliated to Shandong First Medical University', 'geoPoint': {'lat': 36.18528, 'lon': 117.12}}, {'city': 'Linfen', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liyan Guo', 'role': 'CONTACT'}], 'facility': "Linfen People's Hospital", 'geoPoint': {'lat': 36.08889, 'lon': 111.51889}}, {'city': 'Xi’an', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qi Zhou', 'role': 'CONTACT'}], 'facility': "The Second Affiliated Hospital of Xi'an Jiaotong University", 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}, {'city': 'Jiangyou', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Juanjuan Wu', 'role': 'CONTACT'}], 'facility': 'Jiangyou 903 Hospital', 'geoPoint': {'lat': 31.76667, 'lon': 104.71667}}, {'city': 'Chongqing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Min Lu', 'role': 'CONTACT'}], 'facility': 'Bishan Hospital Affiliated to Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Chongqing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoli Zhang', 'role': 'CONTACT'}], 'facility': 'Bishan Hospital Affiliated to Chongqing University of Chinese Medicine (Chongqing Bishan District Hospital of Traditional Chinese Medicine)', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Chongqing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yang Yang', 'role': 'CONTACT'}], 'facility': 'Chongqing Hospital of Traditional Chinese Medicine', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Chongqing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shigen Zhong', 'role': 'CONTACT'}], 'facility': "Chongqing People's Hospital", 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Chongqing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhirong He', 'role': 'CONTACT'}], 'facility': 'Fuling Hospital Affiliated to Chongqing University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Chongqing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanli Guo', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Army Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Chongqing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Haitao Ran', 'role': 'CONTACT'}], 'facility': 'The Second Affiliated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chun Liang', 'role': 'CONTACT'}], 'facility': 'Shanghai Changzheng Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Chunyan Ma the First Hospital of China Medical Univeristy, Ph.D', 'role': 'CONTACT', 'email': 'cmu1h_mcy@126.com', 'phone': '13998816448'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Hospital of China Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Cardiovascular Ultrasound', 'investigatorFullName': 'Chunyan Ma', 'investigatorAffiliation': 'First Hospital of China Medical University'}}}}