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ACTIVE NOT RECRUITING
NCT06911632
NA

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

Sponsor: Tempus AI

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1000

Start Date

2025-07-23

Completion Date

2028-07

Last Updated

2026-04-02

Healthy Volunteers

No

Interventions

DEVICE

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.

PROCEDURE

Echocardiogram and Right Heart Catheterization

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

DEVICE

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.

Locations (25)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Banner University Medical Center

Phoenix, Arizona, United States

Dignity Health - St. Joseph's Hospital and Medical Center-Norton Thoracic Institute

Phoenix, Arizona, United States

National Jewish Health

Denver, Colorado, United States

AdventHealth Orlando

Orlando, Florida, United States

Northwestern University

Chicago, Illinois, United States

University of Illinois Health

Chicago, Illinois, United States

Indiana University Health Methodist Hospital

Indianapolis, Indiana, United States

Community Health Network

Indianapolis, Indiana, United States

University of Kentucky

Lexington, Kentucky, United States

Louisiana State University Health Shreveport

Shreveport, Louisiana, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

University of Michigan - Michigan Medicine

Ann Arbor, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

Hannibal Regional Healthcare System

Hannibal, Missouri, United States

CHI Health Creighton University Medical Center - Bergan Mercy

Omaha, Nebraska, United States

University of Buffalo

Buffalo, New York, United States

Southeastern Research Center

Winston-Salem, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

University of Oklahoma

Oklahoma City, Oklahoma, United States

Temple University of The Commonwealth System of Higher Education

Philadelphia, Pennsylvania, United States

Baylor University Medical Center

Dallas, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

University of Utah

Salt Lake City, Utah, United States

West Virginia University Hospital

Morgantown, West Virginia, United States