A Multicenter Study on the Normal Reference Range and Clinical Significance of the Right Atrioven… (NCT07292896) | Clinical Trial Compass
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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
China2,640 participantsStarted 2025-12
Plain-language summary
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.
Who can participate
Age range18 Years – 79 Years
SexALL
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Inclusion criteria
✓. 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)
✕. Endocrine diseases: thyroid disease, diabetes mellitus, hyperaldosteronism, pheochromocytoma, etc.
✕. 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)
✕. 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.
✕. Pregnant or lactating women
✕. Professional athletes
✕. Poor-quality ultrasound images that cannot support parameter measurement and analysis