A study to evaluate feasibility, diagnostic yield, accuracy, and actionable thresholds of POC, immediate-feedback AI-ECG + AI FoCUS screening for cardiac disease in well described community populations.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
19,300
Focused cardiac ultrasound will utilize sonography to evaluate specific cardiac conditions, such as ventricular function, pericardial effusion, and valvular abnormalities.
A 6-lead ECG uses six electrodes placed on the chest and limbs to record the heart's electrical activity from multiple perspectives.
A standard 12-lead ECG consists of 12 leads: 6 limb leads and 6 chest (precordial) leads. These leads record the heart's electrical activity from different angles to provide a comprehensive assessment of cardiac function.
Mayo Clinic in Rochester
Rochester, Minnesota, United States
RECRUITINGPercentage of participants with positive AI-ECG findings confirmed by echocardiography (Adolescents and young adults)
The percentage will be calculated as the number of participants whose AI-ECG results indicate a positive finding and are subsequently confirmed by echocardiography, divided by the total number of participants assessed, multiplied by 100.
Time frame: Baseline
Number of patients with positive AI-ECG detection for left-right sided SHD (Community Dwelling Adults)
Number of patients with positive AI-ECG detection for left-right sided SHD, defined as any of the following: LVEF \<50%, \>moderate right ventricular systolic dysfunction, \>moderate aortic, mitral, or tricuspid valve regurgitation or stenosis, pulmonary hypertension (right ventricular systolic pressure \> 50 mmHg), or elevated left-sided filling pressure.
Time frame: Baseline
Number of times the AI-ECG provides a correct diagnosis of clinically significant cardiac disease (Pregnant women)
Diagnostic performance of the AI-ECG will be determined by the accurate diagnosis of cardiomyopathy (left ventricular ejection fraction \[LVEF\] ≤50% or 10% or more decline in LVEF) or clinically significant structural heart disease (SHD; ≥ moderate right ventricular systolic dysfunction, ≥ moderate aortic, mitral, or tricuspid valve regurgitation or stenosis, pulmonary hypertension \[right ventricular systolic pressure \> 50 mmHg\], or myocardial disease such as hypertrophic cardiomyopathy) in pregnant patients and those up to 6 weeks postpartum compared to standard of care.
Time frame: Baseline
Number of false positive AI-ECG Results (Adolescents and young adults)
Number of false positive AI-ECG results will be determined by the number of positive AI-ECG results proven false from an echocardiography
Time frame: Baseline
Number of positive AI-ECG results for hypertrophic cardiomyopathy (HCM) (Adolescents and young adults)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The number of positive AI-ECG results for HCM will be based on how many patient ECGs indicate a possible diagnosis of HCM
Time frame: Baseline
Number of positive AI-ECG results for congenital heart defect (CHD) (Adolescents and young adults)
The number of positive AI-ECG results for CHD will be based on how many patient ECGs indicate a possible diagnosis of CHD
Time frame: Baseline
Proportion of patients by age group to receive a diagnosis (Community Dwelling Adults)
Proportion of patients by age group (30-39, 40-49, 50-65, 65-74, and 75 years and older) to receive a diagnosis from ultrasound that is confirmed by a comprehensive diagnostic work up.
Time frame: Baseline
Proportion of total patients to receive a diagnosis based on screening with 6 lead ECG (Community Dwelling Adults)
Proportion of total patients to receive a diagnosis based on screening with 6 lead ECG will be determined by the number of patients to have a correct diagnosis using the 6 lead ECG confirmed by echocardiogram compared to the total number of patients.
Time frame: Baseline
Proportion of total patients to receive a diagnosis based on screening with 12 lead ECG (Community Dwelling Adults)
Proportion of total patients to receive a diagnosis based on screening with 12 lead ECG will be determined by the number of patients to have a correct diagnosis using the 12 lead ECG confirmed by echocardiogram compared to the total number of patients.
Time frame: Baseline
Proportion of total patients to receive a diagnosis based on screening with 12 lead only AI-ECG with adjunctive FoCUS (Community Dwelling Adults)
Proportion of total patients to receive a diagnosis based on screening with 12 lead only AI-ECG with adjunctive FoCUS will be determined by the number of patients to have a correct diagnosis using the 12 lead ECG with adjunctive FoCUS confirmed by standard of care echocardiogram compared to the total number of patients.
Time frame: Baseline
Proportion of total patients to receive a diagnosis based on screening with 12 lead only AI-ECG without adjunctive FoCUS (Community Dwelling Adults)
Proportion of total patients to receive a diagnosis based on screening with 12 lead only AI-ECG without adjunctive FoCUS will be determined by the number of patients to have a correct diagnosis using the 12 lead ECG without adjunctive FoCUS confirmed by standard of care echocardiogram compared to the total number of patients.
Time frame: Baseline
Number of non-cardiac adverse events (Pregnant Women)
Number of non-cardiac adverse events can include hypertensive disorders of pregnancy (gestational hypertension, pre-eclampsia, eclampsia), preterm delivery, gestational diabetes, small for gestational age delivery, placental abruption, and pregnancy loss.
Time frame: Baseline