RECRUITING

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

Description

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 HypertensionInterstitial Lung Disease (ILD)
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Related Conditions:

Pulmonary HypertensionInterstitial Lung Disease (ILD)

Study Overview

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Study Details

Study overview

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.

MOMENTOUS Study (iMpact Of an Ecg ai ModEl oN The Diagnosis Of pUlmonary hypertenSion)

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

Condition
Pulmonary Hypertension
Intervention / Treatment

-

Contacts and Locations

Phoenix

Dignity Health - St. Joseph's Hospital and Medical Center-Norton Thoracic Institute, Phoenix, Arizona, United States, 85013

Chicago

University of Illinois Health, Chicago, Illinois, United States, 60612

Indianapolis

Indiana University Health Methodist Hospital, Indianapolis, Indiana, United States, 46202

Omaha

CHI Health Creighton University Medical Center - Bergan Mercy, Omaha, Nebraska, United States, 68124

Dallas

Baylor University Medical Center, Dallas, Texas, United States, 75246

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Tempus AI,

Study Record Dates

2028-07