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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07292896
Enrollment
2640
Registered
2025-12-18
Start date
2025-12-31
Completion date
2026-12-31
Last updated
2025-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Septal Defect, Healthy Adults, Heart Failure, Pulmonary Hypertension, Tricuspid Regurgitation

Keywords

Right Atrioventricular Coupling Index, 3D Echocardiography, AI-assisted Imaging

Brief 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.

Interventions

None listed

Sponsors

First Hospital of China Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
Yes

Inclusion criteria

Healthy Adults Group Inclusion Criteria: * Participants must meet all of the following criteria to be enrolled: 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

Exclusion criteria

Participants will be excluded if they meet any of the following 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 Inclusion Criteria: 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

Design outcomes

Primary

MeasureTime frameDescription
Right Atrioventricular Coupling Index (RACI)At study enrollment (baseline)RACI links the volumes of the right atrium (RA) and right ventricle (RV), with the degree of their volume matching reflecting their synergistic functional status during hemodynamic regulation

Countries

China

Contacts

Primary ContactChunyan Ma, MD
mcy_echo@163.com+86 13998816448

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026