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
MOMENTOUS Study (iMpact Of an Ecg ai ModEl oN The Diagnosis Of pUlmonary hypertenSion)
Tempus AI
900 participants
Jul 23, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- 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 3 months prior to consent
- Willing and able to provide informed consent and undergo all study-specific procedures, including echo and RHC, if required
Exclusion Criteria8
- 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)
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Interventions
An ECG-based AI device that predicts undiagnosed PH using data from a 12-lead ECG. Device results will be returned to the Investigators.
Echocardiogram- an ultrasound study of the heart and Right Heart Catheterization- a procedure to measure pressures in the heart
An ECG-based AI device that predicts undiagnosed PH using data from a 12-lead ECG. Device results will not be returned to the Investigators.
Locations(25)
View Full Details on ClinicalTrials.gov
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NCT06911632