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The purpose of this study is to evaluate and compare the effectiveness of active screening for SHD in asymptomatic outpatients referred for an ECG, using a combination of AI-ECG and FOCUS. Invites will be sent and participants enrolled electronically.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Integrated pathway |
| ||
| Standard of Care pathway |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI-ECG (artificial intelligence-enabled electrocardiogram) | Diagnostic Test | Participants will undergo electrocardiogram analysis using AI-ECG during the baseline visit |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects to be diagnosed with SHD (structural heart disease) | Percentage of subjects to be diagnosed with SHD will be determined by the number of subjects that have a positive SHD screening. Positive SHD screening is defined by any one of the following: decreased LVEF (left ventricular ejection fraction), cardiac amyloidosis, aortic stenosis, and hypertrophic cardiomyopathy. | Baseline, 6 months, 1 year |
| Positive predictive value (PPV) | Positive predictive value (PPV) will be measured as a percentage. PPV will reflect the percentage of times that each screening pathway matches a formal echocardiogram diagnosis. | Baseline, 6 months, 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of deaths | Number of deaths will include all-cause deaths. | 1 year |
| Number of adverse cardiovascular events | Number of adverse cardiovascular events includes systolic heart failure, rt failure hospitalization. |
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Inclusion Criteria:
Exclusion Criteria:
Prior history of congenital or acquired SHD, as defined by the following
Recent (within last 12 months) echocardiogram
Scheduled clinically indicated future echocardiogram
Inability to provide informed consent to participate in the study
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All subjects aged 18 or older without known congenital or acquired SHD scheduled to undergo an elective outpatient electrocardiogram
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| Name | Affiliation | Role |
|---|---|---|
| Gal Tsaban, M.D., Ph.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| Focus Screening (focused cardiac ultrasonography) | Diagnostic Test | Participants will undergo a focused cardiac ultrasound if the AI-ECG reflects a positive value |
|
| 1 year |
| Percentage of subjects to be diagnosed with decreased LVEF (left ventricular ejection fraction) | Percentage of subjects to be diagnosed with decreased LVEF will be determined by the percentage of subjects to have a LVEF lower than 50%. | Baseline, 6 months,1 year |
| Percentage of subjects to be diagnosed with cardiac amyloidosis | Percentage of subjects to be diagnosed with cardiac amyloidosis will be determined by the number of subjects that have a positive AI-ECG or ultrasound. Cardiac amyloidosis is the buildup of protein in the heart muscle that affect the structure and function of the heart. | Baseline, 6 months,1 year |
| Percentage of subjects to be diagnosed with aortic stenosis | Percentage of subjects to be diagnosed with aortic stenosis will be determined by the number of subjects that have a positive AI-ECG or ultrasound. Aortic stenosis is the narrowing of the aortic value decreasing the blood flow from heart to the aorta. | Baseline, 6 months,1 year |
| Percentage of subjects to be diagnosed with hypertrophic cardiomyopathy | Percentage of subjects to be diagnosed with hypertrophic cardiomyopathy will be determined by the number of subjects that have a positive AI-ECG or ultrasound. Hypertrophic cardiomyopathy is the thickening of the heart muscle which leads to reduced blood flow. | Baseline, 6 months,1 year |