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Clinical Trials in the USA / NCT06911632
Recruiting Not applicable

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

NCT06911632 · tracked via the Priya Life Science USA tracker
Sponsor
Tempus AI
Phase
Not applicable
Started
2025-07-23
Last updated
2026-09-02

Condition(s) studied

Pulmonary HypertensionInterstitial Lung Disease (ILD)

Investigational drug(s) / intervention(s)

ECG-based AI Device - Results Returned to InvestigatorEchocardiogram and Right Heart CatheterizationECG-based AI Device - Results Not Returned to Investigator

ECG-based AI Device - Results Returned to Investigator: An ECG-based AI device that predicts undiagnosed PH using data from a 12-lead ECG. Device results will be returned to the Investigators.

Echocardiogram and Right Heart Catheterization: Echocardiogram- an ultrasound study of the heart and Right Heart Catheterization- a procedure to measure pressures in the heart

ECG-based AI Device - Results Not Returned to Investigator: An ECG-based AI device that predicts undiagnosed PH using data from a 12-lead ECG. Device results will not be returned to the Investigators.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (37)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama Recruiting
Banner University Medical Center Phoenix Arizona Recruiting
Dignity Health - St. Joseph's Hospital and Medical Center-Norton Thoracic Institute Phoenix Arizona Recruiting
HCA Riverside Community Hospital Riverside California Recruiting
National Jewish Health Denver Colorado Recruiting
AdventHealth Orlando Orlando Florida Recruiting
Northwestern University Chicago Illinois Recruiting
University of Illinois Health Chicago Illinois Recruiting
Indiana University Health Methodist Hospital Indianapolis Indiana Recruiting
Community Health Network Indianapolis Indiana Recruiting
University of Kentucky Lexington Kentucky Recruiting
Willis Knighton Health Bossier City Louisiana Recruiting
Louisiana State University Health Shreveport Shreveport Louisiana Recruiting
Brigham and Women's Hospital Boston Massachusetts Recruiting
University of Michigan - Michigan Medicine Ann Arbor Michigan Recruiting
University of Minnesota Minneapolis Minnesota Recruiting
University of Mississippi Medical Center Jackson Mississippi Recruiting
Hannibal Regional Healthcare System Hannibal Missouri Recruiting
Mercy Hospital Springfield Springfield Missouri Recruiting
CHI Health Creighton University Medical Center - Bergan Mercy Omaha Nebraska Recruiting
Renown Regional Medical Center Reno Nevada Recruiting
University of New Mexico Albuquerque New Mexico Recruiting
University of Buffalo Buffalo New York Recruiting
Weill Cornell University Medical College New York New York Recruiting
Southeastern Research Center Winston-Salem North Carolina Recruiting
University Hospitals Cleveland Medical Center Cleveland Ohio Recruiting
University of Oklahoma Oklahoma City Oklahoma Recruiting
Thomas Jefferson University Philadelphia Pennsylvania Recruiting
Temple University of The Commonwealth System of Higher Education Philadelphia Pennsylvania Recruiting
Medical University of South Carolina Charleston South Carolina Recruiting
University of Tennessee Knoxville Tennessee Recruiting
Baylor University Medical Center Dallas Texas Recruiting
Baylor College of Medicine Houston Texas Recruiting
Houston Methodist Hospital Houston Texas Recruiting
University of Utah Salt Lake City Utah Recruiting
Virginia Commonwealth University Richmond Virginia Recruiting
West Virginia University Hospital Morgantown West Virginia Recruiting

More Tempus AI trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06911632 on ClinicalTrials.gov ↗ ← All trials in the USA