ACTIVE_NOT_RECRUITING

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

Conditions

Pulmonary Hypertension Interstitial Lung Disease (ILD)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2025-07-23

Study Completion:2028-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06911632

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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	* 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, 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)

Inclusion Criteria

Exclusion Criteria

* 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

* 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, 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)

Contacts and Locations

Study Locations (Sites)

University of Alabama at Birmingham

Birmingham, Alabama, 35205

United States

Banner University Medical Center

Phoenix, Arizona, 84006

United States

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

Phoenix, Arizona, 85013

United States

National Jewish Health

Denver, Colorado, 80206

United States

AdventHealth Orlando

Orlando, Florida, 32803

United States

Northwestern University

Chicago, Illinois, 60611

United States

University of Illinois Health

Chicago, Illinois, 60612

United States

Indiana University Health Methodist Hospital

Indianapolis, Indiana, 46202

United States

Community Health Network

Indianapolis, Indiana, 46237

United States

University of Kentucky

Lexington, Kentucky, 40536

United States

Louisiana State University Health Shreveport

Shreveport, Louisiana, 71102

United States

University of Michigan - Michigan Medicine

Ann Arbor, Michigan, 48109-5360

United States

University of Minnesota

Minneapolis, Minnesota, 55455

United States

CHI Health Creighton University Medical Center - Bergan Mercy

Omaha, Nebraska, 68124

United States

University of Buffalo

Buffalo, New York, 14203

United States

Southeastern Research Center

Winston-Salem, North Carolina, 27103

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44121

United States

University of Oklahoma

Oklahoma City, Oklahoma, 73104

United States

Temple University of The Commonwealth System of Higher Education

Philadelphia, Pennsylvania, 19140

United States

Baylor University Medical Center

Dallas, Texas, 75246

United States

Baylor College of Medicine

Houston, Texas, 77030

United States

University of Utah

Salt Lake City, Utah, 84103

United States

West Virginia University Hospital

Morgantown, West Virginia, 26505

United States

Collaborators and Investigators

Sponsor: Tempus AI

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-23

Study Completion Date2028-07

Study Record Updates

Study Start Date2025-07-23

Study Completion Date2028-07

Terms related to this study

Keywords Provided by Researchers

Pulmonary Hypertension
Interstitial lung disease (ILD)

Additional Relevant MeSH Terms

Pulmonary Hypertension
Interstitial Lung Disease (ILD)