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 (MOMENTOUS)

Tempus AI

Status: Active, not recruiting

Conditions: Interstitial Lung Disease (ILD); Pulmonary Hypertension

Treatments: Device: ECG-based AI Device - Results Returned to Investigator; Procedure: Echocardiogram and Right Heart Catheterization; Device: ECG-based AI Device - Results Not Returned to Investigator

Study type: Interventional

Funder types: Industry

Identifiers

NCT06911632

TP-CA-008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion 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

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, 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)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 4 patient groups

High Risk Device

Experimental group

Description:

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.

Treatment:

Procedure: Echocardiogram and Right Heart Catheterization

Device: ECG-based AI Device - Results Returned to Investigator

Not High Risk Device

Experimental group

Description:

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.

Treatment:

Device: ECG-based AI Device - Results Returned to Investigator

High Risk Control Arm

Other group

Description:

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.

Treatment:

Device: ECG-based AI Device - Results Not Returned to Investigator

Not High Risk Control Arm

Other group

Description:

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.

Treatment:

Device: ECG-based AI Device - Results Not Returned to Investigator