MOMENTOUS Study (iMpact Of an Ecg ai ModEl oN The Diagnosis Of pUlmonary hypertenSion)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Tempus AI
- 入组人数
- 900
- 试验地点
- 54
- 主要终点
- Proportion of participants receiving a new diagnosis of PH within the High risk Device group compared to the High risk Control group.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
For participants in the Device group, the risk prediction will be returned to the treating provider whereas the providers will be blinded to the risk predictions for participants in the Control group.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: ECG-based AI Device - Results Returned to Investigator (Device)
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.
干预措施: Echocardiogram and Right Heart Catheterization (Procedure)
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.
干预措施: ECG-based AI Device - Results Returned to Investigator (Device)
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.
干预措施: ECG-based AI Device - Results Not Returned to Investigator (Device)
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.
干预措施: ECG-based AI Device - Results Not Returned to Investigator (Device)
结局指标
主要结局
Proportion of participants receiving a new diagnosis of PH within the High risk Device group compared to the High risk Control group.
时间窗: Through study completion, approximately 6 months
Mean pulmonary artery pressure (mPAP) \> 20 mm Hg and pulmonary vascular resistance (PVR) \> 2 Wood units
次要结局
- Proportion of participants receiving a new diagnosis of PH within the Device group compared to the Control group.(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.(Through study completion, approximately 6 months)