Cardiac Disease
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTAI-ECG (artificial intelligence-enabled electrocardiogram)
Participants will undergo electrocardiogram analysis using AI-ECG during the baseline visit
DIAGNOSTIC_TESTFocus Screening (focused cardiac ultrasonography)
Participants will undergo a focused cardiac ultrasound if the AI-ECG reflects a positive value
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult patients (\>18 years of age) * Echocardiogram is not clinically indicated
Exclusion criteria
* Prior history of congenital or acquired SHD, as defined by the following 1. Aortic Stenosis: 2. Heart Failure 3. Left Ventricular Dysfunction 4. Cardiac Amyloidosis 5. Hypertrophic Cardiomyopathy (HCM) 6. Rheumatic Heart Disease 7. Congenital Heart Disease * Recent (within last 12 months) echocardiogram * Scheduled clinically indicated future echocardiogram * Inability to provide informed consent to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of subjects to be diagnosed with SHD (structural heart disease) | Baseline, 6 months, 1 year | 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. |
| Positive predictive value (PPV) | Baseline, 6 months, 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of deaths | 1 year | Number of deaths will include all-cause deaths. |
| Number of adverse cardiovascular events | 1 year | Number of adverse cardiovascular events includes systolic heart failure, rt failure hospitalization. |
| Percentage of subjects to be diagnosed with decreased LVEF (left ventricular ejection fraction) | Baseline, 6 months,1 year | Percentage of subjects to be diagnosed with decreased LVEF will be determined by the percentage of subjects to have a LVEF lower than 50%. |
| Percentage of subjects to be diagnosed with cardiac amyloidosis | Baseline, 6 months,1 year | 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. |
| Percentage of subjects to be diagnosed with aortic stenosis | Baseline, 6 months,1 year | 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. |
| Percentage of subjects to be diagnosed with hypertrophic cardiomyopathy | Baseline, 6 months,1 year | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGal Tsaban, M.D., Ph.D.
Mayo Clinic
Outcome results
None listed