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
Sites (25)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Anshan Central Hospital Coordinator of this site? Confirm its status | Anshan | China | Unknown status |
| Ansteel Group General Hospita Coordinator of this site? Confirm its status | Anshan | China | Unknown status |
| Beijing Chaoyang Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The Second Affiliated Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Chaoyang Central Hospital Coordinator of this site? Confirm its status | Chaoyang | China | Unknown status |
| West China Hospital,Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Chongqing Liangjiang New Area Hospital of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| The Second Hospital of Dalian Medical University Coordinator of this site? Confirm its status | Dalian | China | Unknown status |
| The Fourth Affiliated Hospital of Harbin Medical University Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| The First Affiliated Hospital of Harbin Medical University Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| Huludao Second People's Hospital Coordinator of this site? Confirm its status | Huludao | China | Unknown status |
| Liaohua Hospital Coordinator of this site? Confirm its status | Liaoyang | China | Unknown status |
| The Affiliated Hospital of Qingdao University Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
| Zhongshan Hospital, Fudan University, Shanghai Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shanghai Chest Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| The First Hospital of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| Shenzhen People's Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
| The Third Affiliated Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijiazhuang | China | Unknown status |
| Shijiazhuang People's Hospital Coordinator of this site? Confirm its status | Shijiazhuang | China | Unknown status |
| Shanxi Provincial People's Hospital Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| The First Affiliated Hospital of Xi'an Jiaotong University Coordinator of this site? Confirm its status | Xi’an | China | Unknown status |
| Xiangyang No.1 Peoples Hospital Coordinator of this site? Confirm its status | Xiangyang | China | Unknown status |
| The Second Affiliated Hospital of Shaanxi University of Chinese Medicine Coordinator of this site? Confirm its status | Xianyang | China | Unknown status |
| Henan Provincial People's Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.