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Two recently developed artificial intelligence-enabled electrocardiogram (AI-ECG) models have been developed to detect aortic stenosis (AS) and diastolic dysfunction (DD). AI-ECG for AS has a sensitivity of 78% and specificity of 74%, and AI-ECG for DD has a sensitivity of 83% and specificity of 80%. However, these models have never been prospectively applied to diagnose AS or DD, which may be useful for patients and providers from a diagnostic and prognostic perspective and especially in settings where access to higher- level medical care is limited. In this study, we aim to determine the clinical utility of these AI-ECG models by prospectively applying them to an outpatient cohort and then completing a focused point-of-care ultrasound to evaluate those who are AI-ECG positive for AS and DD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who are completing an outpatient electrocardiogram (ECG) at the Mayo Clinic. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI-ECG Dashboard | Device | Patients standard of care ECG's will be processed through the AI-ECG Dashboard |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with positive AI-ECG | Positive AI-ECG will be determined by the sensitivity, specificity, positive predictive value, and negative predictive value. | Baseline |
| Number of studies with reasonable image quality in patients with positive AI-ECG | Image quality will be determined by sonographers at the time of imaging and will be scored on a scale from 1-4:
| Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Number of times the AI ECG and TTE (transthoracic echocardiogram) are statistically comparative | Will be compared using parametric (2-sample t-test) and non-parametric tests (Wilcoxon rank sum test) for continuous variables, and the χ2 test or Fisher exact test for nominal variables. A p-value of < 0.05 will be categorized as significant for the statistical analysis | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who are completing an outpatient electrocardiogram (ECG) at the Mayo Clinic.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brian Rudquist | Contact | (507) 538-5146 | Rudquist.Brian@mayo.edu | |
| Jae Oh, M.D. | Contact | oh.jae@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jae Oh, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Point of care ultrasound (POCUS) | Diagnostic Test | Patients will undergo a ultrasound to confirm diagnosis of atrial stenosis or diastolic dysfunction. |
|
| D014694 |
| Ventricular Outflow Obstruction |