Screening Cardiometabolic Opportunities Using Transformative Echocardiography Artificial Intelligence (SCOUT Echo-AI)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,000
- 试验地点
- 7
- 主要终点
- Positive Predictive Value (PPV) of the AI algorithm for detecting MASLD and/or cirrhosis confirmed within 12 months of AI identification.
研究概览
简要总结
The goal of this prospective, multicenter, open-label, blinded end-point pragmatic study is to evaluate an artificial intelligence (AI)-augmented echocardiography screening approach for early detection of metabolic dysfunction associated steatotic liver disease (MASLD) and/or cirrhosis, in patients undergoing routine transthoracic echocardiograms (TTEs).
The main question it aims to answer is to:
- Evaluate notification responsiveness and rates of confirmatory testing for patients identified as high risk for having liver disease to determine whether optimized notifications increase timely confirmatory testing and treatment initiation versus standard of care assessment.
- Compare time to diagnosis, treatment uptake, and clinical outcomes (hospitalizations, incident ASCVD, mortality) between cohorts identified as high risk by the AI algorithm and comparison groups to determine whether AI guided screening shortens time to diagnosis and increases appropriate treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Adults ≥18 years.
- •Underwent routine TTE within site defined recent timeframe and flagged as high risk for MASLD and/or cirrhosis by the AI model using pre specified threshold.
- •Able to provide informed consent; reachable for follow up.
排除标准
- •Inability to consent or communicate.
- •Enrollment in hospice or life expectancy so limited that additional evaluation would not be appropriate per clinician judgment.
- •Clinical circumstances where immediate alternative diagnostic pathways supersede study procedures (e.g., acute decompensation requiring urgent management).
- •Prior liver or kidney transplant.
- •Patient unwilling to undergo prospective testing for liver disease.
研究组 & 干预措施
AI Notification (EchoNet-Liver-Flagged patients)
Participants whose prior transthoracic echocardiograms are flagged by an AI model (EchoNet-Liver) as high risk for MASLD and/or cirrhosis, a notification is delivered to the primary treating clinician, or undergoes a structured diagnostic workflow for standard of care at their site.
干预措施: AI-Enabled Identification (EchoNet-Liver) (Other)
结局指标
主要结局
Positive Predictive Value (PPV) of the AI algorithm for detecting MASLD and/or cirrhosis confirmed within 12 months of AI identification.
时间窗: From enrollment to end of follow up at 1 year.
Numerator: Participants with clinician-confirmed diagnosis of later stage MASLD and/or cirrhosis after confirmatory evaluation. Denominator: * Participants with positive AI screen who were enrolled and evaluated. * The intervention is the clinician referral or referral testing workflow. The clinicians ultimately have discretion to avoid further downstream testing if pretest probability is felt to be too low. If a clinician determines no further testing is warranted despite high risk assessment by AI, the participant will be classified as a false positive (still counted in the denominator).
次要结局
- Time to diagnosis of MASLD/cirrhosis(Followed up to 24 months post notification.)
- Time to diagnosis for MASLD with F2 fibrosis or greater(Followed up to 24 months post notification.)
- Time to diagnosis for steatotic liver disease(Followed up to 24 months post notification.)
- Time to confirmatory imaging(Followed up to 24 months post notification.)
- Time to initiation of targeted treatment(Followed up to 24 months post notification.)
- All-cause mortality(Followed up to 24 months post notification.)
- All-cause hospitalization(Followed up to 24 months post notification.)
- Heart failure hospitalization(Followed up to 24 months post notification.)
- Cardiovascular hospitalization(Followed up to 24 months post notification.)
- Hepatic decompensation hospitalization(Followed up to 24 months post notification.)
- New ASCVD diagnosis(Followed up to 24 months post notification.)
研究者
David Ouyang
Int Med-Cardio Non-Invasive
Kaiser Permanente