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

• Interstitial Lung Disease (ILD)
• Pulmonary Hypertension

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ECG-based AI Device - Results Returned to Investigator — DEVICE
  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 — PROCEDURE
  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 — DEVICE
  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.

Study Details

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.

Key Dates

Start date

Jul 23, 2025

Status verified

Apr 2026

Primary completion

May 31, 2028

Completion

Jul 31, 2028

Study Design

Enrollment

900 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Arms

• 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.

Primary Outcome Measure

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 ]

Central Contacts

• Momentous Study
  (833) 514-4187
  [email protected]

Locations (25)

Find similar trials in Birmingham, AL

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