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

NCT07292896 | Not Yet Recruiting DMC

• 1 other identifier: 3D-RACI-01
• Study Type: observational
• Target: 2,640
• Locations: 1 country
• Sites: 25

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.

Conditions

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

Keywords

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

Outcome Measures

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

  At study enrollment (baseline)

Study Arms (5)

Healthy Adults Group

Healthy adults aged 18 to 79 years are planned to be stratified into 6 age groups: 18-29 years, 30-39 years, 40-49 years, 50-59 years, 60-69 years, and ≥70 years. Each age group will include 120 participants of each sex.

Pulmonary Hypertension Group

This group comprises adults with a confirmed diagnosis of mean pulmonary artery pressure (mPAP) ≥20 mmHg via right heart catheterization, in accordance with the diagnostic criteria for pulmonary hypertension specified in the 2022 ESC/ERS Guidelines.

Tricuspid Regurgitation Group

Adults with moderate or severe primary/secondary tricuspid regurgitation confirmed by echocardiography.

Atrial Septal Defect Group

Adults with atrial septal defect confirmed by echocardiography or transesophageal echocardiography, including non-intervened patients, those who underwent closure/surgical correction, and stable patients \> 3 months after surgery.

Heart Failure Group

Adults meeting the 2022 AHA/ACC/HFSA diagnostic criteria for heart failure are classified into three subgroups based on left ventricular ejection fraction (LVEF): heart failure with reduced ejection fraction (HFrEF, LVEF \< 40%), heart failure with mildly reduced ejection fraction (HFmrEF, LVEF 40-49%), and heart failure with preserved ejection fraction (HFpEF, LVEF ≥ 50%).

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• Patients will be excluded if they meet any of the following criteria:
• Unable to complete right heart catheterization or pressure-volume loop assessment

Sponsors & Collaborators

• First Hospital of China Medical University: lead

Study Sites (25)

Chongqing Liangjiang New Area Hospital of Traditional Chinese Medicine

Chongqing, Chongqing Municipality, China

Location

Shenzhen People's Hospital

Shenzhen, Guangdong, China

Location

Shijiazhuang People's Hospital

Shijiazhuang, Hebei, China

Location

The Third Affiliated Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Location

The Fourth Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Location

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Location

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

Xiangyang No.1 Peoples Hospital

Xiangyang, Hubei, China

Location

The Second Affiliated Hospital of Jilin University

Changchun, Jilin, China

Location

Anshan Central Hospital

Anshan, Liaoning, China

Location

Ansteel Group General Hospita

Anshan, Liaoning, China

Location

Chaoyang Central Hospital

Chaoyang, Liaoning, China

Location

the Second Hospital of Dalian Medical University

Dalian, Liaoning, China

Location

Huludao Second People's Hospital

Huludao, Liaoning, China

Location

Liaohua Hospital

Liaoyang, Liaoning, China

Location

The First Hospital of China Medical University

Shenyang, Liaoning, 110000, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Location

The Second Affiliated Hospital of Shaanxi University of Chinese Medicine

Xianyang, Shaanxi, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Location

Shanxi Provincial People's Hospital

Taiyuan, Shanxi, China

Location

West China Hospital，Sichuan University

Chengdu, Sichuan, China

Location

Beijing Chaoyang Hospital, Capital Medical University

Beijing, China

Location

Shanghai Chest Hospital

Shanghai, China

Location

Zhongshan Hospital, Fudan University, Shanghai

Shanghai, China

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Tricuspid Valve Insufficiency; Heart Failure; Heart Septal Defects, Atrial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Heart Valve Diseases; Heart Diseases; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Chunyan Ma, MD

  First Hospital of China Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunyan Ma, MD

CONTACT

+86 13998816448; mcy_echo@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Cardiovascular Ultrasound

Study Record Dates

• First Submitted: December 6, 2025
• First Posted: December 18, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (25)