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.
Study Type
OBSERVATIONAL
Enrollment
10,500
Participants will undergo electrocardiogram analysis using AI-ECG during the baseline visit
Participants will undergo a focused cardiac ultrasound if the AI-ECG reflects a positive value
Mayo Clinic
Rochester, Minnesota, United States
RECRUITINGPercentage 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.
Time frame: 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.
Time frame: Baseline, 6 months, 1 year
Number of deaths
Number of deaths will include all-cause deaths.
Time frame: 1 year
Number of adverse cardiovascular events
Number of adverse cardiovascular events includes systolic heart failure, rt failure hospitalization.
Time frame: 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%.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: Baseline, 6 months,1 year