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NCT07292896Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 18 Dec 2025

Brief summary (registry, in English)

This multicenter study aims to establish the normal reference range of the Right Atrioventricular Coupling Index (RACI) in healthy Chinese adults using AI-based 3DE technology. It will also analyze the correlation between RACI and physiological parameters such as age, gender, and body surface area. Additionally, the study will explore the variation characteristics of RACI in patients with pulmonary hypertension, heart failure, tricuspid regurgitation, and atrial septal defect, and evaluate the clinical value of RACI in disease diagnosis, differential diagnosis, and risk stratification.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
2640 (estimated)
First submitted
6 Dec 2025
Start date
Dec 2025
Primary completion date
Dec 2026
Lead sponsor
First Hospital of China Medical University
NCT number
NCT07292896

What you commit to

  • Study type: Observational
  • Planned participants: 2640
  • From Dec 2025 to the primary completion date, Dec 2026
  • 25 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concurrent liver or renal disease
  • Concurrent malignancy

Other illness

  • Clinically significant cardiac valve regurgitation (≥ mild severity)
  • Respiratory diseases: acute or chronic respiratory disorders
  • Endocrine diseases: thyroid disease, diabetes mellitus, hyperaldosteronism, pheochromocytoma, etc.
  • 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.
  • Poor-quality ultrasound images that cannot support parameter measurement and analysis
    • Pulmonary Hypertension Group
  • Unable to complete right heart catheterization or pressure-volume loop assessment
  • Pericardial disease or arrhythmias (e.g., atrial fibrillation) that severely impair right heart function evaluation
  • History of surgical procedures such as pulmonary endarterectomy or balloon pulmonary angioplasty
    • Heart Failure Group
  • 1.Complicated with significant valvular heart disease (e.g., severe mitral regurgitation, severe tricuspid regurgitation, etc.)
  • Pericardial disease or arrhythmias (persistent atrial fibrillation) that interfere with measurements
  • Congenital heart disease or residual lesions after surgical correction
    • Atrial Septal Defect Group
  • 1.Complicated with other complex congenital heart diseases.

Lab values

  • 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)
  • Complicated with significant left heart disease (left ventricular ejection fraction \[LVEF\] \< 50%, significant mitral valve disease)

Other

  • Participants will be excluded if they meet any of the following criteria:
  • Pregnant or lactating women
  • Professional athletes
  • Patients will be excluded if they meet any of the following criteria:
  • Poor-quality images that prevent accurate measurement of right atrial or right ventricular parameters
  • Patients will be excluded if they meet any of the following criteria:
  • Tricuspid Regurgitation Group
  • Patients will be excluded if they meet any of the following criteria:

Who the study is looking for

  • Participants must meet all of the following criteria to be enrolled:
    • Of Han Chinese ethnicity
    • Aged 18-79 years
    • Normal blood pressure (\< 140/90 mmHg)
    • Normal fasting blood glucose
    • Normal blood lipid levels (triglycerides, total cholesterol, low-density lipoprotein, high-density lipoprotein)
    • Normal complete blood count results (hemoglobin concentration, white blood cell count, red blood cell count, platelet count)
    • Normal liver and renal function (alanine transaminase \< 2× upper limit of normal; normal creatinine and blood urea nitrogen)
    • Normal electrocardiogram results (occasional atrial premature beats may be enrolled at the investigator's discretion)
    • No structural heart disease and normal cardiac function confirmed by echocardiography
  • Patients must meet all of the following criteria to be enrolled:
  • Aged 18-79 years
  • 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:
  • Aged 18-79 years
  • Meets the 2022 AHA/ACC/HFSA diagnostic criteria for heart failure
  • Patients must meet all of the following criteria to be enrolled:
  • Moderate or severe primary or secondary tricuspid regurgitation confirmed by echocardiography
  • Aged 18-79 years
  • Patients must meet all of the following criteria to be enrolled:
  • Secundum atrial septal defect confirmed by echocardiography or transesophageal echocardiography
  • Patients who have not undergone closure or surgical correction, or stable patients with \> 3 months postoperatively
  • Aged 18-79 years

Criteria the registry did not label

  • Healthy Adults Group

Age in the registry: 18 years to 79 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (25)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Anshan Central Hospital
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AnshanChinaUnknown status
Ansteel Group General Hospita
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AnshanChinaUnknown status
Beijing Chaoyang Hospital, Capital Medical University
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BeijingChinaUnknown status
The Second Affiliated Hospital of Jilin University
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ChangchunChinaUnknown status
Chaoyang Central Hospital
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ChaoyangChinaUnknown status
West China Hospital,Sichuan University
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ChengduChinaUnknown status
Chongqing Liangjiang New Area Hospital of Traditional Chinese Medicine
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ChongqingChinaUnknown status
The Second Hospital of Dalian Medical University
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DalianChinaUnknown status
The Fourth Affiliated Hospital of Harbin Medical University
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HarbinChinaUnknown status
The First Affiliated Hospital of Harbin Medical University
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HarbinChinaUnknown status
Huludao Second People's Hospital
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HuludaoChinaUnknown status
Liaohua Hospital
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LiaoyangChinaUnknown status
The Affiliated Hospital of Qingdao University
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QingdaoChinaUnknown status
Zhongshan Hospital, Fudan University, Shanghai
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ShanghaiChinaUnknown status
Shanghai Chest Hospital
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ShanghaiChinaUnknown status
The First Hospital of China Medical University
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ShenyangChinaUnknown status
Shenzhen People's Hospital
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ShenzhenChinaUnknown status
The Third Affiliated Hospital of Hebei Medical University
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ShijiazhuangChinaUnknown status
Shijiazhuang People's Hospital
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ShijiazhuangChinaUnknown status
Shanxi Provincial People's Hospital
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TaiyuanChinaUnknown status
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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WuhanChinaUnknown status
The First Affiliated Hospital of Xi'an Jiaotong University
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Xi’anChinaUnknown status
Xiangyang No.1 Peoples Hospital
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XiangyangChinaUnknown status
The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
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XianyangChinaUnknown status
Henan Provincial People's Hospital
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ZhengzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.