RecruitingPulmonary HypertensionInterstitial Lung Disease (ILD)

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

Eligible age

18+ yrs

Accepts

All genders

Locations

26 states

Healthy volunteers

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About this study

MOMENTOUS is a multi-center, randomized study to prospectively evaluate the performance of an ECG-based AI device to predict whether participants with interstitial lung disease (ILD) are at high risk of undiagnosed pulmonary hypertension.

Sponsor: Tempus AI

You may qualify if…

✓ 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

You may not qualify if…

✕ 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)