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| ID | Type | Description | Link |
|---|---|---|---|
| 25AHAAI1487693 | Other Grant/Funding Number | American Heart Association |
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| Name | Class |
|---|---|
| Stanford University | OTHER |
| Massachusetts General Hospital | OTHER |
| Cedars-Sinai Medical Center | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AI Notification (EchoNet-Liver-Flagged patients) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI-Enabled Identification (EchoNet-Liver) | Other | AI-generated notifications to clinicians about possible undiagnosed liver disease (MASLD and/or Cirrhosis) detected from Transthoracic Echocardiogram |
| Measure | Description | Time Frame |
|---|---|---|
| Positive Predictive Value (PPV) of the AI algorithm for detecting MASLD and/or cirrhosis confirmed within 12 months of AI identification. | Numerator: Participants with clinician-confirmed diagnosis of later stage MASLD and/or cirrhosis after confirmatory evaluation. Denominator:
| From enrollment to end of follow up at 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to diagnosis of MASLD/cirrhosis | Time (days) from AI identification to first confirmatory diagnosis | Followed up to 24 months post notification. |
| Time to diagnosis for MASLD with F2 fibrosis or greater |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90034 | United States |
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Time (days) from AI identification to first confirmatory diagnosis
| Followed up to 24 months post notification. |
| Time to diagnosis for steatotic liver disease | Time (days) from AI identification to first confirmatory diagnosis | Followed up to 24 months post notification. |
| Time to confirmatory imaging | Time (days) from AI identification | Followed up to 24 months post notification. |
| Time to initiation of targeted treatment | Time (days) from AI identification | Followed up to 24 months post notification. |
| All-cause mortality | Time (days) from AI identification | Followed up to 24 months post notification. |
| All-cause hospitalization | Time (days) from AI identification | Followed up to 24 months post notification. |
| Heart failure hospitalization | Time (days) from AI identification (Defined as admission with IV diuretics or elevated BNP) | Followed up to 24 months post notification. |
| Cardiovascular hospitalization | Time (days) from AI identification for Cardiovascular hospitalization (defined by principal ICD9/10 code) | Followed up to 24 months post notification. |
| Hepatic decompensation hospitalization | Time (days) from AI identification for hepatic decompensation hospitalization (defined by ascites, hepatic encephalopathy, variceal bleeding, hepatocellular carcinoma, or liver transplantation) | Followed up to 24 months post notification. |
| New ASCVD diagnosis | Time (days) from AI identification | Followed up to 24 months post notification. |
| Stanford Healthcare | Palo Alto | California | 94588 | United States |
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| Kaiser Permanente | Pleasanton | California | 94588 | United States |
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| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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