NCT07292896尚未招募不适用
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
First Hospital of China Medical University25 个研究点 分布在 1 个国家目标入组 2,640 人开始时间: 2025年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,640
- 试验地点
- 25
- 主要终点
- Right Atrioventricular Coupling Index (RACI)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •Inclusion Criteria:
- •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
- •Exclusion Criteria:
- •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
- •Inclusion Criteria:
- •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
- •Exclusion Criteria:
- •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
- •Inclusion Criteria:
- •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
- •Exclusion Criteria:
- •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
- •Inclusion Criteria:
- •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 Criteria:
- •1.Complicated with other complex congenital heart diseases.
结局指标
主要结局
Right Atrioventricular Coupling Index (RACI)
时间窗: 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
次要结局
未报告次要终点
研究者
Chunyan Ma
Chief of Cardiovascular Ultrasound
First Hospital of China Medical University
研究点 (25)
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