Study of an ECG-based AI Device to Help Detect Pulmonary Hypertension in Adults with Interstitial Lung Disease

What this Trial Is About

Researchers are evaluating an ECG-based artificial intelligence AI device designed to predict whether patients with interstitial lung disease ILD are at high risk for undiagnosed pulmonary hypertension PH. This multi-center, randomized study aims to determine if using this AI device can increase the rate of new PH diagnoses over a 6-month period compared to the current standard of care. Participants with ILD will undergo a 12-lead ECG, which the AI device will analyze to assess PH risk. Participants are randomly assigned to either the Device group, where investigators receive the AI device results, or the Control group, where results are not shared. Those in the Device group identified as high risk will receive additional tests including a transthoracic echocardiogram and right heart catheterization RHC. Participants not identified as high risk and all Control group participants will continue with standard care as determined by their physicians. Throughout the study, participants will be monitored over approximately 6 months to track new PH diagnoses. Assessments include ECGs, echocardiograms, RHC procedures if indicated, and ongoing clinical evaluations. Researchers will compare the proportion of new PH diagnoses between groups while ensuring participants receive appropriate care based on their risk and physician recommendations.

Multi-site Study of the Clinical Impact of an AI-assisted Approach to Referring Patients With Interstitial Lung Disease for Diagnostic Evaluation of Pulmonary Hypertension