MOMENTOUS Study (iMpact Of an Ecg ai ModEl oN The Diagnosis Of pUlmonary hypertenSion)
Status: Recruiting
Location: See all (18) locations...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Arizona
Dignity Health - St. Joseph's Hospital and Medical Center-Norton Thoracic Institute
RECRUITING
Phoenix
Colorado
National Jewish Health
RECRUITING
Denver
Florida
AdventHealth Orlando
RECRUITING
Orlando
Illinois
Northwestern University
RECRUITING
Chicago
University of Illinois Health
RECRUITING
Chicago
Indiana
Indiana University Health Methodist Hospital
RECRUITING
Indianapolis
Kentucky
University of Kentucky
RECRUITING
Lexington
Louisiana
Louisiana State University Health Shreveport
RECRUITING
Shreveport
Michigan
University of Michigan - Michigan Medicine
RECRUITING
Ann Arbor
Minnesota
University of Minnesota
RECRUITING
Minneapolis
North Carolina
Southeastern Research Center
RECRUITING
Winston-salem
Nebraska
CHI Health Creighton University Medical Center - Bergan Mercy
RECRUITING
Omaha
Ohio
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
Pennsylvania
Temple University of The Commonwealth System of Higher Education
RECRUITING
Philadelphia
Texas
Baylor University Medical Center
RECRUITING
Dallas
Utah
University of Utah
RECRUITING
Salt Lake City
West Virginia
West Virginia University Hospital
RECRUITING
Morgantown
Contact Information
Primary
Momentous Study
momentous-study@tempus.com
(833) 514-4187
Time Frame
Start Date: 2025-07-23
Estimated Completion Date: 2028-07
Participants
Target number of participants: 1000
Treatments
Experimental: High Risk Device
The device result will be returned to the treating provider and participants will undergo a study sponsored diagnostic work-up consisting of a transthoracic echocardiogram and an RHC.
Experimental: Not High Risk Device
The device result will be returned to the treating provider. Participants will continue to be evaluated for PH according to the current standard of care with any diagnostic procedures ordered at the discretion of the treating provider.
Other: High Risk Control Arm
The device result will not be returned to the treating provider. Participants will continue to be evaluated for PH according to the current standard of care with any diagnostic procedures ordered at the discretion of the treating provider.
Other: Not High Risk Control Arm
The device result will not be returned to the treating provider. Participants will continue to be evaluated for PH according to the current standard of care with any diagnostic procedures ordered at the discretion of the treating provider.
Related Therapeutic Areas
Sponsors
Leads: Tempus AI
Collaborators: United Therapeutics