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

Sponsor
First Hospital of China Medical University
Study ID
NCT07292896
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 79 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

First listed
Dec 18, 2025
Start date
Dec 31, 2025
Status verified
Nov 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
2,640 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: Tricuspid Regurgitation Group
    Adults with moderate or severe primary/secondary tricuspid regurgitation confirmed by echocardiography.
  • Arm: 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.
  • Arm: 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%).

Primary Outcome Measure

Right Atrioventricular Coupling Index (RACI) [ Time Frame: At study enrollment (baseline) ]

Central Contacts

Find similar trials

Nationwide
Heart failure trialsCardiology trialsHeart disease trials

Related Studies