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

Обзор

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.

Первичные конечные точки

• Right Atrioventricular Coupling Index (RACI) [Срок оценки: At study enrollment (baseline)]

Критерии участия

Healthy Adults Group

Критерии включения

• 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

Критерии исключения

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

• 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)
• 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

Pulmonary Hypertension Group

Критерии включения

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

Критерии исключения

Patients will be excluded if they meet any of the following criteria:

• Unable to complete right heart catheterization or pressure-volume loop assessment
• Complicated with significant left heart disease (left ventricular ejection fraction \[LVEF\] < 50%, significant mitral valve disease)
• Pericardial disease or arrhythmias (e.g., atrial fibrillation) that severely impair right heart function evaluation
• Poor-quality images that prevent accurate measurement of right atrial or right ventricular parameters
• Concurrent liver or renal disease
• Concurrent malignancy
• History of surgical procedures such as pulmonary endarterectomy or balloon pulmonary angioplasty

Heart Failure Group

Критерии включения

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

Критерии исключения

Patients will be excluded if they meet any of the following criteria:

1.Complicated with significant valvular heart disease (e.g., severe mitral regurgitation, severe tricuspid regurgitation, etc.)

Tricuspid Regurgitation Group

Критерии включения

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

Критерии исключения

Patients will be excluded if they meet any of the following criteria:

• Pericardial disease or arrhythmias (persistent atrial fibrillation) that interfere with measurements
• Congenital heart disease or residual lesions after surgical correction

Atrial Septal Defect Group

Критерии включения

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

Критерии исключения

1.Complicated with other complex congenital heart diseases.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 25 центров

• Chongqing Liangjiang New Area Hospital of Traditional Chinese Medicine — Чунцин
• Shenzhen People's Hospital — Шэньчжэнь
• Shijiazhuang People's Hospital — Shijiazhuang
• The Third Affiliated Hospital of Hebei Medical University — Shijiazhuang
• The First Affiliated Hospital of Harbin Medical University — Харбин
• The Fourth Affiliated Hospital of Harbin Medical University — Харбин
• Henan Provincial People's Hospital — Чжэнчжоу
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Ухань
• … и ещё 17 центров

Идентификаторы

NCT: NCT07292896 · 3D-RACI-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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