RecruitingRecruiting
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
NCT06911632 · Tempus AI
In plain English
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Official title
MOMENTOUS Study (iMpact Of an Ecg ai ModEl oN The Diagnosis Of pUlmonary hypertenSion)
About this study
The goal of this study is to evaluate the use of an ECG-based AI device that may help predict if participants with interstitial lung disease (ILD) are at high risk of undiagnosed pulmonary hypertension (PH). The study seeks to determine whether use of the device increases the rate of new PH diagnoses over a period of 6 months as compared to current standard of care.
The study will recruit participants with ILD from lung disease clinics who will each receive a 12-lead ECG (a test that measures the electrical activity of the heart) following consent. The device will analyze the 12-lead ECG results to identify participants that are at high risk of having undiagnosed PH.
Participants will be randomly assigned to either the Device or Control group. For participants in the Device group investigators will receive the results of the device. In the Control group investigators will not receive the results of the device. Additionally, participants in the Device group identified as "high risk" by the device will receive a transthoracic echocardiogram and a right heart catheterization (RHC). Participants in the Device group who are not high risk and all participants in the Control group will not receive these additional tests as part of the study, but will receive standard of care treatment as determined by their physicians, which may include an echocardiogram or RHC if clinically indicated.
Eligibility criteria
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 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 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)
Study design
Enrollment target: 900 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-07-23
Estimated completion: 2028-07
Last updated: 2026-05-04
Interventions
Device: ECG-based AI Device - Results Returned to InvestigatorProcedure: Echocardiogram and Right Heart CatheterizationDevice: ECG-based AI Device - Results Not Returned to Investigator
Primary outcomes
- • Proportion of participants receiving a new diagnosis of PH within the High risk Device group compared to the High risk Control group. (Through study completion, approximately 6 months)
Sponsor
Tempus AI · industry
With: United Therapeutics
Contacts & investigators
ContactMomentous Study · contact · momentous-study@tempus.com · (833) 514-4187
All locations (25)
University of Alabama at BirminghamRecruiting
Birmingham, Alabama, United States
Banner University Medical CenterRecruiting
Phoenix, Arizona, United States
Dignity Health - St. Joseph's Hospital and Medical Center-Norton Thoracic InstituteRecruiting
Phoenix, Arizona, United States
National Jewish HealthRecruiting
Denver, Colorado, United States
AdventHealth OrlandoRecruiting
Orlando, Florida, United States
Northwestern UniversityRecruiting
Chicago, Illinois, United States
University of Illinois HealthRecruiting
Chicago, Illinois, United States
Indiana University Health Methodist HospitalRecruiting
Indianapolis, Indiana, United States
Community Health NetworkRecruiting
Indianapolis, Indiana, United States
University of KentuckyRecruiting
Lexington, Kentucky, United States
Louisiana State University Health ShreveportRecruiting
Shreveport, Louisiana, United States
Brigham and Women's HospitalRecruiting
Boston, Massachusetts, United States
University of Michigan - Michigan MedicineRecruiting
Ann Arbor, Michigan, United States
University of MinnesotaRecruiting
Minneapolis, Minnesota, United States
Hannibal Regional Healthcare SystemRecruiting
Hannibal, Missouri, United States
CHI Health Creighton University Medical Center - Bergan MercyRecruiting
Omaha, Nebraska, United States
University of BuffaloRecruiting
Buffalo, New York, United States
Southeastern Research CenterRecruiting
Winston-Salem, North Carolina, United States
University Hospitals Cleveland Medical CenterRecruiting
Cleveland, Ohio, United States
University of OklahomaRecruiting
Oklahoma City, Oklahoma, United States
Temple University of The Commonwealth System of Higher EducationRecruiting
Philadelphia, Pennsylvania, United States
Baylor University Medical CenterRecruiting
Dallas, Texas, United States
Baylor College of MedicineRecruiting
Houston, Texas, United States
University of UtahRecruiting
Salt Lake City, Utah, United States
West Virginia University HospitalRecruiting
Morgantown, West Virginia, United States