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
Purpose
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.
Conditions
- Pulmonary Hypertension
- Interstitial Lung Disease (ILD)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 18 years or older at the time of consent - A known diagnosis of interstitial lung disease - 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, 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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- An ECG-based AI device, will provide a prediction of a participant's risk of having undiagnosed pulmonary hypertension. Participants with a high risk prediction in the Device group will undergo a transthoracic echocardiogram and a right heart catheterization (RHC). All other participants will receive standard of care treatment.
- Primary Purpose
- Diagnostic
- Masking
- None (Open Label)
- Masking Description
- For participants in the Device group, the risk prediction will be returned to the treating provider whereas the providers will be blinded to the risk predictions for participants in the Control group.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental High Risk Device |
The device result will be returned to the treating provider and participants will undergo a study sponsored diagnostic work-up consisting of a transthoracic echocardiogram and an RHC. |
|
|
Experimental Not High Risk Device |
The device result will be returned to the treating provider. Participants will continue to be evaluated for PH according to the current standard of care with any diagnostic procedures ordered at the discretion of the treating provider. |
|
|
Other High Risk Control Arm |
The device result will not be returned to the treating provider. Participants will continue to be evaluated for PH according to the current standard of care with any diagnostic procedures ordered at the discretion of the treating provider. |
|
|
Other Not High Risk Control Arm |
The device result will not be returned to the treating provider. Participants will continue to be evaluated for PH according to the current standard of care with any diagnostic procedures ordered at the discretion of the treating provider. |
|
Recruiting Locations
Birmingham 4049979, Alabama 4829764 35205
More Details
- Status
- Recruiting
- Sponsor
- Tempus AI
Detailed Description
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.