MOMENTOUS study (iMpact Of an ecg ai ModEl oN The diagnosis Of pUlmonary hypertenSion)

Investigating an Investigational Device for Pulmonary Hypertension Risk in ILD Patients

O
Onyedika Ilonze

Primary Investigator

Enrolling By Invitation
18 years - 100 years
All
Phase N/A
100 participants needed
1 Location

Brief description of 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.

THIS STUDY IS ENROLLING BY INVITATION ONLY -   Potential participants will be identified and screened from the ILD clinic.

Detailed description of study

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 of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Interstitial Lung Disease, ILD, Pulmonary Hypertension
  • Age: 18 years - 100 years
  • Gender: All

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)

This study investigates the use of an ECG-based artificial intelligence (AI) device to assess the risk of undiagnosed pulmonary hypertension (PH) in patients with interstitial lung disease (ILD). The purpose of this study is to determine if the device can increase the rate of new PH diagnoses compared to the current standard of care over a six-month period. Pulmonary hypertension is a condition where there is high blood pressure in the blood vessels that supply the lungs, which can lead to serious health issues.

Participants will be randomly assigned to either the Device arm or the Control arm. In the Device arm, investigators will receive the device's results, and if participants are identified as "high risk," they will undergo further testing with a transthoracic echocardiogram and a right heart catheterization (RHC). In the Control arm, investigators will not receive the device's results, and participants will receive standard care. A 12-lead ECG, a test that measures the heart's electrical activity, will be conducted for all participants.

  • Who can participate: Adults aged 18 and older with a known diagnosis of interstitial lung disease are eligible to participate. Participants must be willing and able to provide informed consent and undergo study procedures. Those with a known diagnosis of pulmonary hypertension or certain medical conditions may be excluded.
  • Study details: Participants will be randomly assigned to either the Device or Control arm. Those in the Device arm will have their ECG results analyzed by the AI device. If identified as high risk, they will receive additional tests like an echocardiogram and right heart catheterization. Participants in the Control arm will receive standard care.
  • Study timelines: The study will last 6 months.
Updated on 28 Jul 2025. Study ID: KIC-TEMPUS-ILONZE-MOMENTOUS, 27264
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only