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
NCT ID: NCT06911632
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1000 participants
INTERVENTIONAL
2025-07-23
2028-07-31
Brief Summary
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Detailed Description
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The study will recruit participants with ILD from lung disease clinics who will each receive a 12-lead ECG (a test that measures the electrical activity of the heart) following consent. The device will analyze the 12-lead ECG results to identify participants that are at high risk of having undiagnosed PH.
Participants will be randomly assigned to either the Device or Control group. For participants in the Device group investigators will receive the results of the device. In the Control group investigators will not receive the results of the device. Additionally, participants in the Device group identified as "high risk" by the device will receive a transthoracic echocardiogram and a right heart catheterization (RHC). Participants in the Device group who are not high risk and all participants in the Control group will not receive these additional tests as part of the study, but will receive standard of care treatment as determined by their physicians, which may include an echocardiogram or RHC if clinically indicated.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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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.
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
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.
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.
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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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United Therapeutics
INDUSTRY
Tempus AI
INDUSTRY
Responsible Party
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Locations
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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
University of Kentucky
Lexington, Kentucky, United States
Louisiana State University Health Shreveport
Shreveport, Louisiana, United States
University of Michigan - Michigan Medicine
Ann Arbor, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
CHI Health Creighton University Medical Center - Bergan Mercy
Omaha, Nebraska, 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
University of Utah
Salt Lake City, Utah, United States
West Virginia University Hospital
Morgantown, West Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Andrea Ford
Role: primary
Clinical Research Coordinator
Role: primary
Dominique Robertson
Role: primary
Adrea Arthofer
Role: primary
Kimberly Stark
Role: primary
Taryn Holt
Role: primary
Dustin Fraidenburg, MD
Role: primary
Isabell Mwaura
Role: primary
Srushan Bhaktula
Role: primary
Teresa Leeth
Role: primary
Catherine Crombez
Role: primary
Mandi DeGrote
Role: primary
Chloe Andersen
Role: primary
Lauren Miller
Role: primary
Jennie Pexa
Role: primary
Maria Mason
Role: primary
Kimberly Selwood
Role: primary
Brianna Kamran
Role: primary
Stefanos Lakonios
Role: primary
Chad Glaze
Role: primary
Other Identifiers
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TP-CA-008
Identifier Type: -
Identifier Source: org_study_id