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AI Echocardiographic Screening of Cardiac Amyloidosis

Artificial Intelligence Guided Echocardiographic Screening of Rare Diseases (EchoNet-Screening)

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06664866
Enrollment
500
Registered
2024-10-30
Start date
2024-10-28
Completion date
2027-11-01
Last updated
2026-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Amyloidosis

Brief summary

Recent advances in machine learning and image processing techniques have shown that machine learning models can identify features unrecognized by human experts and accurately assess common measurements made in clinical practice. Echocardiography is the most common form of cardiac imaging and is routinely and frequently used for diagnosis. However, there is often subjectivity and heterogeneity in interpretation. Artificial intelligence (AI)'s ability for precision measurement and detection is important in both disease screening as well as diagnosis of cardiovascular disease. Cardiac amyloidosis (CA) is a rare, underdiagnosed disease with targeted therapies that reduce morbidity and increase life expectancy. However, CA is frequently overlooked and confused with heart failure with preserved ejection fraction. Some estimates suggest that CA can be as prevalence as 1% in a general population, with even higher prevalence in patients with left ventricular hypertrophy, heart failure, and other cardiac symptoms that might prompt echocardiography. AI guided disease screening workflows have been proposed for rare diseases such as cardiac amyloidosis and other diseases with relatively low prevalence but significant human impact with targeted therapies when detected early. This is an area particularly suitable for AI as there are multiple mimics where diseases like hypertrophic cardiomyopathy, cardiac amyloidosis, aortic stenosis, and other phenotypes might visually be similar but can be distinguished by AI algorithms. The investigators have developed an algorithm, termed EchoNet-LVH, to identify cardiac hypertrophy and identify patients who would benefit from additional screening for cardiac amyloidosis.

Interventions

DIAGNOSTIC_TESTEchoNet-LVH Assessment

The AI algorithm is previously described (Duffy et al. JAMA Cardiology 2022) and will remain unchanged throughout the course of the study. A pre-determined threshold based on prior experiments and analysis has been decided prior to the study. From each site, approximately 100,000 echocardiogram studies will be reviewed by EchoNet-LVH for approximately 500 patients to be flagged.

Sponsors

Cedars-Sinai Medical Center
Lead SponsorOTHER
Palo Alto Veteran Affairs Hospital
CollaboratorUNKNOWN
Providence Heart & Vascular Institute
CollaboratorOTHER
Northwestern Medicine
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients receiving an echocardiogram that is determined to be suspicious by EchoNet-LVH

Exclusion criteria

* Patients that decline consent * Patients receiving an echocardiogram that is determined to be not suspicious by EchoNet-LVH

Design outcomes

Primary

MeasureTime frameDescription
Positive Predictive Value1 year1. Among patients that screening positive and consented to the trial, the proportion of patients that subsequently are confirmed to have CA upon clinical follow-up. 2. Statistical Analysis: Fisher's exact (two-sided) for superiority Comparison with PPV of standard clinical suspicion (PPV of all comers that receive Tc-99m PYP/HDP imaging scan or other clinical diagnosis).

Secondary

MeasureTime frameDescription
Time to Diagnosis from Echocardiogram Study to Clinical Diagnosis1 yearStatistical Analysis: Cox proportional hazards test with comparison with of Study population vs. comparison with Patients with echocardiogram study showing at least moderate left ventricular hypertrophy by human interpretation.
Number of Patients that Receive Treatment for CA1 year
Number of Cardiac Amyloidosis Diagnoses1 year
Number of Participants with All Cause Death1 year
Number of Participants with All Cause Hospitalization1 year
Number of Participants with Heart Failure Hospitalization1 yeardefined as needing IV diuretics or BNP higher than baseline or ICD9/10 code

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORLily Stern, MD

Cedars-Sinai Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 23, 2026