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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-79
SponsorFirst Hospital of China Medical University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Of Han Chinese ethnicity

Aged 18-79 years

Normal blood pressure (< 140/90 mmHg)

Normal fasting blood glucose

Disqualifiers

Clinically significant cardiac valve regurgitation (≥ mild severity)

Respiratory diseases: acute or chronic respiratory disorders

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)

Trial population

This study enrolls 5 groups (18-79 years) from clinics/community: Healthy Adults: Han Chinese with normal cardiovascular function (vitals, labs, ECG, echo; no structural heart disease/systemic diseases/poor ultrasound). Pulmonary Hypertension: Diagnosed via right heart catheter (mPAP ≥20 mmHg, 2022 ESC/ERS); excluded if with left heart disease, interfering conditions, organ dysfunction, malignancy, or prior pulmonary surgery. Heart Failure: Meets 2022 AHA/ACC/HFSA criteria; excluded if with significant valvular disease. Tricuspid Regurgitation: Echo-confirmed moderate/severe regurgitation; excluded if with interfering pericardial/arrhythmic issues or congenital heart disease/residual lesions. Atrial Septal Defect: Echo/TEE-confirmed secundum defect (untreated or stable ≥3mo post-op); excluded if with complex congenital heart disease. All undergo standardized clinical/echo assessments for cardiac structure/function.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

2,640 Participants
are grouped into 5 trial groups
Group A: Healthy Adults Group
Group B: Pulmonary Hypertension Group
Group C: Tricuspid Regurgitation Group
Group D: Atrial Septal Defect Group
Group E: Heart Failure Group

Trial outcomes

Primary outcomes

1

Right Atrioventricular Coupling Index (RACI)

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

Time frame
At study enrollment (baseline)

Secondary outcomes

Other outcomes

Sponsors and contacts

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