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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

RecruitingNAAges 18 Years - anyAllTempus AI
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ค 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)
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What it tests

  • ECG-based AI Device - Results Returned to Investigator
  • Echocardiogram and Right Heart Catheterization
  • ECG-based AI Device - Results Not Returned to Investigator
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Where

40 sites
University of Alabama at Birmingham
Birmingham, United States
Banner University Medical Center
Phoenix, United States
Dignity Health - St. Joseph's Hospital and Medical Center-Norton Thoracic Institute
Phoenix, United States
University of Arkansas
Little Rock, United States
HCA Riverside Community Hospital
Riverside, United States
National Jewish Health
Denver, United States
AdventHealth Orlando
Orlando, United States
Northwestern University
Chicago, United States

โ€ฆand 32 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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