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

Official title

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

Overview

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.

Detailed description

The goal of this study is to evaluate the use of an ECG-based AI device that may help predict if participants with interstitial lung disease (ILD) are at high risk of undiagnosed pulmonary hypertension (PH). The study seeks to determine whether use of the device increases the rate of new PH diagnoses over a period of 6 months as compared to current standard of care.

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.

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.

Primary outcome measures

• Proportion of participants receiving a new diagnosis of PH within the High risk Device group compared to the High risk Control group. [Time frame: Through study completion, approximately 6 months]

Secondary outcome measures (2)

• Proportion of participants receiving a new diagnosis of PH within the Device group compared to the Control group. [Time frame: Through study completion, approximately 6 months]
• Proportion of participants receiving a new diagnosis of PH within the High risk Device group compared to the Not high risk Device group. [Time frame: Through study completion, approximately 6 months]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Diagnostic

Study locations

United States · 32 centers

• University of Alabama at Birmingham — Birmingham
• Banner University Medical Center — Phoenix
• Dignity Health - St. Joseph's Hospital and Medical Center-Norton Thoracic Institute — Phoenix
• National Jewish Health — Denver
• AdventHealth Orlando — Orlando
• Northwestern University — Chicago
• University of Illinois Health — Chicago
• Indiana University Health Methodist Hospital — Indianapolis
• … and 24 more centers

Identifiers

NCT: NCT06911632 · TP-CA-008

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗