StudyFinder
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
RECRUITING
18 years and over
Inclusion Criteria:
* 18 years or older at the time of consent
* A known diagnosis of interstitial lung disease
* Diffusing capacity for carbon monoxide (DLCO) \<30% predicted, collected within 6 months prior to consent
* Willing and able to provide informed consent and undergo all study-specific procedures, including echo and RHC, if required
Exclusion Criteria:
* A known diagnosis of pulmonary hypertension (including patients prescribed a therapy specifically for pulmonary arterial hypertension (PAH))
* A RHC was completed within the previous 1 year or ordered and not yet completed at the time of consent
* LV ejection fraction ≤ 40% on most recent echo or cardiac MRI, if available
* Unclassifiable Tempus PH ECG risk result after up to 2 ECG acquisitions
* A contraindication to RHC exists (for example, pregnancy or mechanical right heart valve)
* Physician decision that if a patient is directed to RHC by the study protocol, the potential risks of RHC outweigh the potential benefits
* There is a severe concomitant illness limiting life expectancy to less than 6 months (at the discretion of the investigator)
* There is a medical or social factor that makes the patient a poor candidate for the study and/or unlikely to be able to comply with the study protocol or complete study procedures (at the discretion of the investigator)DEVICE: ECG-based AI Device - Results Returned to Investigator, PROCEDURE: Echocardiogram and Right Heart Catheterization, DEVICE: ECG-based AI Device - Results Not Returned to Investigator
Pulmonary Hypertension, Interstitial Lung Disease (ILD)
Pulmonary Hypertension, Interstitial lung disease (ILD)
Momentous Study - momentous-study@tempus.com
NCT06911632