Measuring right heart coupling with AI-assisted 3D ultrasound in healthy adults and heart patients

Trial details

Who runs it

First Hospital of China Medical University

Trial code

NCT07292896

Record updated

18 December 2025

Original description

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.Read full original descriptionShow less

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

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.

Inclusion: 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.

Exclusion: Concurrent liver or renal disease; Concurrent malignancy; 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; 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); 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:.

Healthy Adults Group.

ClinicalTrials.gov NCT07292896