Heart Disease
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTFocused Cardiac Ultrasound
Focused cardiac ultrasound will utilize sonography to evaluate specific cardiac conditions, such as ventricular function, pericardial effusion, and valvular abnormalities.
DIAGNOSTIC_TEST6-Lead AI-ECG
A 6-lead ECG uses six electrodes placed on the chest and limbs to record the heart's electrical activity from multiple perspectives.
DIAGNOSTIC_TEST12-Lead AI-ECG
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.
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adolescents and young adults: Inclusion Criteria: * Enrollment in a high-school, college or a resident in MN during the study period * Age 18-29 years * Informed consent (and assent for minors)
Exclusion criteria
* Presence of a pacemaker or defibrillator * Inability to obtain a quality ECG tracing Community dwelling adults: Inclusion Criteria: • Adult patients (\>30 years of age, with pre-specified subgroups 30-64 and 65+))
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with positive AI-ECG findings confirmed by echocardiography (Adolescents and young adults) | Baseline | 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. |
| Number of patients with positive AI-ECG detection for left-right sided SHD (Community Dwelling Adults) | Baseline | 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. |
| Number of times the AI-ECG provides a correct diagnosis of clinically significant cardiac disease (Pregnant women) | Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of false positive AI-ECG Results (Adolescents and young adults) | Baseline | Number of false positive AI-ECG results will be determined by the number of positive AI-ECG results proven false from an echocardiography |
| Number of positive AI-ECG results for hypertrophic cardiomyopathy (HCM) (Adolescents and young adults) | Baseline | The number of positive AI-ECG results for HCM will be based on how many patient ECGs indicate a possible diagnosis of HCM |
| Number of positive AI-ECG results for congenital heart defect (CHD) (Adolescents and young adults) | Baseline | The number of positive AI-ECG results for CHD will be based on how many patient ECGs indicate a possible diagnosis of CHD |
| Proportion of patients by age group to receive a diagnosis (Community Dwelling Adults) | Baseline | 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. |
| Proportion of total patients to receive a diagnosis based on screening with 6 lead ECG (Community Dwelling Adults) | Baseline | 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. |
| Proportion of total patients to receive a diagnosis based on screening with 12 lead ECG (Community Dwelling Adults) | Baseline | 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. |
| Proportion of total patients to receive a diagnosis based on screening with 12 lead only AI-ECG with adjunctive FoCUS (Community Dwelling Adults) | Baseline | 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. |
| Proportion of total patients to receive a diagnosis based on screening with 12 lead only AI-ECG without adjunctive FoCUS (Community Dwelling Adults) | Baseline | 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. |
| Number of non-cardiac adverse events (Pregnant Women) | Baseline | 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. |
Countries
United States
Contacts
CONTACTAmanda Priebe
PRINCIPAL_INVESTIGATORPaul Friedman, MD
Mayo Clinic
Outcome results
None listed