A Multicenter Study on the Normal Reference Range and Clinical Significance of the Right Atrioventricular Coupling Index Assessed by Artificial Intelligence-Based Three-Dimensional Echocardiography
NCT ID: NCT07292896
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
2640 participants
OBSERVATIONAL
2025-12-31
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Healthy Adults Group
Healthy adults aged 18 to 79 years are planned to be stratified into 6 age groups: 18-29 years, 30-39 years, 40-49 years, 50-59 years, 60-69 years, and ≥70 years. Each age group will include 120 participants of each sex.
No interventions assigned to this group
Pulmonary Hypertension Group
This group comprises adults with a confirmed diagnosis of mean pulmonary artery pressure (mPAP) ≥20 mmHg via right heart catheterization, in accordance with the diagnostic criteria for pulmonary hypertension specified in the 2022 ESC/ERS Guidelines.
No interventions assigned to this group
Tricuspid Regurgitation Group
Adults with moderate or severe primary/secondary tricuspid regurgitation confirmed by echocardiography.
No interventions assigned to this group
Atrial Septal Defect Group
Adults with atrial septal defect confirmed by echocardiography or transesophageal echocardiography, including non-intervened patients, those who underwent closure/surgical correction, and stable patients \> 3 months after surgery.
No interventions assigned to this group
Heart Failure Group
Adults meeting the 2022 AHA/ACC/HFSA diagnostic criteria for heart failure are classified into three subgroups based on left ventricular ejection fraction (LVEF): heart failure with reduced ejection fraction (HFrEF, LVEF \< 40%), heart failure with mildly reduced ejection fraction (HFmrEF, LVEF 40-49%), and heart failure with preserved ejection fraction (HFpEF, LVEF ≥ 50%).
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
1. Of Han Chinese ethnicity
2. Aged 18-79 years
3. Normal blood pressure (\< 140/90 mmHg)
4. Normal fasting blood glucose
5. Normal blood lipid levels (triglycerides, total cholesterol, low-density lipoprotein, high-density lipoprotein)
6. Normal complete blood count results (hemoglobin concentration, white blood cell count, red blood cell count, platelet count)
7. Normal liver and renal function (alanine transaminase \< 2× upper limit of normal; normal creatinine and blood urea nitrogen)
8. Normal electrocardiogram results (occasional atrial premature beats may be enrolled at the investigator's discretion)
9. No structural heart disease and normal cardiac function confirmed by echocardiography
Patients must meet all of the following criteria to be enrolled:
1. Aged 18-79 years
2. Confirmed diagnosis via right heart catheterization: mean pulmonary arterial pressure (mPAP) ≥ 20 mmHg, in accordance with the 2022 ESC/ERS guidelines
Patients must meet all of the following criteria to be enrolled:
1. Aged 18-79 years
2. Meets the 2022 AHA/ACC/HFSA diagnostic criteria for heart failure
Patients must meet all of the following criteria to be enrolled:
1. Moderate or severe primary or secondary tricuspid regurgitation confirmed by echocardiography
2. Aged 18-79 years
Patients must meet all of the following criteria to be enrolled:
1. Secundum atrial septal defect confirmed by echocardiography or transesophageal echocardiography
2. Patients who have not undergone closure or surgical correction, or stable patients with \> 3 months postoperatively
3. Aged 18-79 years
Exclusion Criteria
1. Clinically significant cardiac valve regurgitation (≥ mild severity)
2. Respiratory diseases: acute or chronic respiratory disorders
3. Endocrine diseases: thyroid disease, diabetes mellitus, hyperaldosteronism, pheochromocytoma, etc.
4. Abnormal liver function (alanine transaminase \> 2× upper limit of normal), abnormal renal function (elevated creatinine beyond normal range), or dyslipidemia (elevated triglycerides, total cholesterol, low-density lipoprotein, or high-density lipoprotein)
5. Other systemic diseases: anemia, malignancy, connective tissue disease, large artery/peripheral vascular diseases (aortic dilation, aortic dissection, coarctation of the aorta, Takayasu arteritis, atherosclerosis), etc.
6. Pregnant or lactating women
7. Professional athletes
8. Poor-quality ultrasound images that cannot support parameter measurement and analysis
Pulmonary Hypertension Group
Patients will be excluded if they meet any of the following criteria:
1. Unable to complete right heart catheterization or pressure-volume loop assessment
2. Complicated with significant left heart disease (left ventricular ejection fraction \[LVEF\] \< 50%, significant mitral valve disease)
3. Pericardial disease or arrhythmias (e.g., atrial fibrillation) that severely impair right heart function evaluation
4. Poor-quality images that prevent accurate measurement of right atrial or right ventricular parameters
5. Concurrent liver or renal disease
6. Concurrent malignancy
7. History of surgical procedures such as pulmonary endarterectomy or balloon pulmonary angioplasty
Heart Failure Group
Patients will be excluded if they meet any of the following criteria:
1.Complicated with significant valvular heart disease (e.g., severe mitral regurgitation, severe tricuspid regurgitation, etc.)
Tricuspid Regurgitation Group
Patients will be excluded if they meet any of the following criteria:
1. Pericardial disease or arrhythmias (persistent atrial fibrillation) that interfere with measurements
2. Congenital heart disease or residual lesions after surgical correction
Atrial Septal Defect Group
1.Complicated with other complex congenital heart diseases.
18 Years
79 Years
ALL
Yes
Sponsors
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First Hospital of China Medical University
OTHER
Responsible Party
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Chunyan Ma
Chief of Cardiovascular Ultrasound
Principal Investigators
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Chunyan Ma, MD
Role: PRINCIPAL_INVESTIGATOR
First Hospital of China Medical University
Locations
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Chongqing Liangjiang New Area Hospital of Traditional Chinese Medicine
Chongqing, Chongqing Municipality, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
Shijiazhuang People's Hospital
Shijiazhuang, Hebei, China
The Third Affiliated Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Xiangyang No.1 Peoples Hospital
Xiangyang, Hubei, China
The Second Affiliated Hospital of Jilin University
Changchun, Jilin, China
Anshan Central Hospital
Anshan, Liaoning, China
Ansteel Group General Hospita
Anshan, Liaoning, China
Chaoyang Central Hospital
Chaoyang, Liaoning, China
the Second Hospital of Dalian Medical University
Dalian, Liaoning, China
Huludao Second People's Hospital
Huludao, Liaoning, China
Liaohua Hospital
Liaoyang, Liaoning, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
Xianyang, Shaanxi, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, China
West China Hospital，Sichuan University
Chengdu, Sichuan, China
Beijing Chaoyang Hospital, Capital Medical University
Beijing, , China
Shanghai Chest Hospital
Shanghai, , China
Zhongshan Hospital, Fudan University, Shanghai
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Yan Zhang
Role: primary
Xiaoqing Yang
Role: primary
Heping Deng
Role: primary
Hui Liu
Role: primary
Tianle Yu
Role: primary
Haohui Zhu, PhD
Role: primary
Yu Wang, Ph.D
Role: primary
Dongmei Lv
Role: primary
Yao Wang
Role: primary
Gang Du, Ph.D
Role: primary
Hong Zhou
Role: primary
Jun Wu
Role: primary
Xuan Wang
Role: primary
Shuangyan Liu
Role: primary
Chunyan Ma, MD
Role: primary
Chunyan Ma, MD
Role: backup
Shun Wang
Role: primary
Xiaoli Zhu
Role: primary
Weiqing Li
Role: primary
Yidan Li
Role: primary
fan li
Role: primary
Xianhong Shu
Role: primary
Other Identifiers
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3D-RACI-01
Identifier Type: -
Identifier Source: org_study_id