Doctors are testing a new tool called EchoNext to see if it can help find heart problems earlier. EchoNext looks at the heart's electrical test, called an ECG, and uses artificial intelligence (AI) to check for signs of structural heart disease (SHD). SHD includes conditions like weak heart pumping, heart valve problems, or extra thickening of the heart muscle. These problems are common but often go undiagnosed until they cause serious issues like heart failure or stroke. The main questions this study will answer are: Can EchoNext alerts help emergency doctors find hidden heart problems sooner? Does this lead to more follow-up heart tests, like an echocardiogram (heart ultrasound)? What this means for patients: If a person has an ECG in the Emergency Department, the EchoNext tool may be used to check their heart. If the tool finds something unusual, their doctor may receive an alert and may then recommend further heart tests or follow-up care. This study will help researchers learn if using EchoNext improves early diagnosis and treatment of heart disease.
Structural heart disease (SHD) is a major cause of illness and death, especially in older adults. SHD includes conditions such as valvular heart disease (e.g., aortic stenosis, mitral regurgitation), left or right ventricular dysfunction, left ventricular hypertrophy, pulmonary artery hypertension, and pericardial effusions. These conditions are often underdiagnosed, and delayed recognition can lead to complications such as heart failure, stroke, and cardiomyopathy. Early detection and treatment can improve outcomes, but current approaches often miss patients in the early stages of disease. EchoNext is an artificial intelligence model trained on over 400,000 ECG-echocardiogram pairs. It analyzes the standard 12-lead ECG to predict the presence of structural heart disease, as defined by echocardiographic findings. The model has demonstrated strong diagnostic performance, with an area under the receiver operating characteristic (AUROC) curve of 0.86 across diverse populations. The purpose of this trial is to evaluate whether deploying EchoNext into the Emergency Department (ED) electronic health record (EHR) as a clinical decision support alert can increase the detection of undiagnosed SHD. The ED setting is ideal because: (1) ECGs are widely obtained for many presenting complaints, (2) abnormal ECG findings related to SHD are often overlooked in the acute setting, and (3) EDs provide access to disadvantaged populations and a unique opportunity to deliver population-level interventions. In this study, ECGs obtained in the ED will be analyzed in real time by the EchoNext model. If the model predicts moderate or severe SHD, an EHR alert will be displayed to the treating provider (attending physician, fellow, resident, physician assistant, or nurse practitioner). The alert will inform providers of the potential for underlying SHD and recommend consideration of follow-up echocardiography or specialty referral. Outcomes will include rates of new SHD diagnoses confirmed by echocardiography, follow-up testing and referrals, and downstream patient outcomes. The Community Tele-Paramedicine (CTP) program, an established post-discharge care initiative at NewYork-Presbyterian, will also serve as a follow-up resource for patients identified in the ED. CTP combines home visits by community paramedics, telehealth visits by emergency physicians, and nurse care management to coordinate outpatient testing and follow-up care. Integration with CTP will facilitate timely echocardiography and referral for patients flagged by EchoNext, particularly for high-risk or underserved populations. This trial will determine whether AI-driven ECG interpretation can improve early detection of SHD and lead to better patient outcomes compared to standard care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
4,000
EKG Algorithm to identify structural heart disease
Columbia University Irving Medical Center / NewYork-Presbyterian
New York, New York, United States
RECRUITINGNumber of new diagnoses of Structural Heart Disease (SHD)
Number of patients with a new diagnosis of structural heart disease (SHD), including moderate or greater valvular disease, left or right ventricular systolic dysfunction, left ventricular hypertrophy, pulmonary artery hypertension, or moderate/large pericardial effusions, confirmed by echocardiography or other clinical evaluation.
Time frame: 180 days post index ED visit
Rate of echocardiography ordering
Proportion of patients who received an echocardiogram following the index ED visit.
Time frame: 180 days post index ED visit
New Medical Treatments for SHD
Number of patients initiating new cardiovascular medications (e.g., antihypertensives, diuretics) specifically for treatment of structural heart disease.
Time frame: 180 days post index ED visit
New Surgical or Procedural Interventions for SHD
Number of patients undergoing procedural interventions for SHD, including valve repair/replacement, cardiac surgery, drainage of pericardial effusion, or implanted defibrillator placement.
Time frame: 180 days post-index ED visit
Long-Term Medical Treatments for SHD
Number of patients who initiated new cardiovascular medications (e.g., antihypertensives, diuretics) for treatment of structural heart disease within 1 year.
Time frame: 1 year post-index ED visit
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.