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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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Heart tracing (ECG)

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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 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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether an AI tool using an ECG, a test of the heart’s electrical signals, can find people at high risk for pulmonary hypertension that has not been diagnosed. Pulmonary hypertension means high blood pressure in the lungs. The study is for adults with interstitial lung disease, a group of diseases that scar or inflame the lungs.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are at least 18 years old when you agree to join.
  • You have been diagnosed with interstitial lung disease.
  • Within the past 6 months, your DLCO result was below 30% of the expected value. This breathing test measures how well gas moves from your lungs into your blood.
  • You are willing and able to give informed consent and complete all study tests. These may include an echo (heart ultrasound) and right heart catheterization, or RHC (a thin tube placed into the right side of the heart to measure pressure).

Who can't join

  • You already have pulmonary hypertension, including if you take medicine specifically for pulmonary arterial hypertension, a type of high blood pressure in the lungs.
  • You had an RHC in the past year, or one has been ordered but not yet done when you agree to join.
  • Your latest heart ultrasound or heart MRI, if available, shows that your heart’s main pumping chamber pumps out 40% or less of its blood with each beat.
  • The study’s AI tool cannot give a risk result after up to 2 ECG tests.
  • You have a condition that prevents RHC, such as pregnancy or a mechanical valve on the right side of your heart.
  • Your doctor thinks the risks of RHC would outweigh the benefits if the study calls for this test.
  • The study doctor believes another serious illness limits your life expectancy to less than 6 months.
  • The study doctor believes a health or social issue makes the study a poor fit or makes you unlikely to follow the study plan or finish its tests.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 6 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 sites (40)

AL

AR

AZ

CA

CO

FL

IL

IN

KY

LA

MA

MI

MN

MO

MS

NC

NE

NM

NV

NY

OH

OK

PA

SC

TN

TX

UT

VA

WV