Study Using AI-Enabled ECG and Focused Cardiac Ultrasound to Screen for Heart Disease in Adolescents, Adults, and Pregnant Women

What this Trial Is About

Researchers are evaluating the use of AI-enabled electrocardiography AI-ECG and focused cardiac ultrasound FoCUS to screen for heart disease in different community populations. The study aims to assess the feasibility, diagnostic accuracy, and actionable results of point-of-care immediate-feedback AI-ECG combined with AI FoCUS screening. The populations include adolescents and young adults, community-dwelling adults, and pregnant women. Participants will undergo diagnostic tests including a 6-lead AI-ECG, a 12-lead AI-ECG, and focused cardiac ultrasound using sonography to assess heart functions such as ventricular function, pericardial effusion, and valvular abnormalities. The study includes three groups community adults over 30 years old, pregnant women aged 18 to 49 receiving obstetric care, and adolescents and young adults aged 15 to 29 years. Each group will be screened using these AI-assisted cardiac tests. During the study, participants will have ECGs and ultrasounds performed to detect cardiac abnormalities. Researchers will measure how often AI-ECG findings are confirmed by echocardiography and the number of correct AI-ECG diagnoses of significant cardiac disease. They will also track false positives and diagnoses of specific heart conditions. Safety events in pregnant women will be monitored. The study involves baseline evaluations and will continue through the study period ending in early 2028.

A Study Of Heart Disease Using AI-Enabled Electrocardiography And Focused Cardiac Ultrasound