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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Community dwelling adults | Experimental |
| |
| Pregnant women | Experimental |
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| Adolescents and young adults | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Focused Cardiac Ultrasound | Diagnostic Test | Focused cardiac ultrasound will utilize sonography to evaluate specific cardiac conditions, such as ventricular function, pericardial effusion, and valvular abnormalities. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage 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. | 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. | 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. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline |
| Number of positive AI-ECG results for hypertrophic cardiomyopathy (HCM) (Adolescents and young adults) |
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Adolescents and young adults:
Inclusion Criteria:
Exclusion Criteria:
Community dwelling adults:
Inclusion Criteria:
• Adult patients (>30 years of age, with pre-specified subgroups 30-64 and 65+))
Exclusion Criteria:
• Inability to provide informed consent to participate in the study
Pregnant women:
Inclusion Criteria:
Exclusion Criteria:
• Inability to provide consent
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amanda Priebe | Contact | 507-422-6932 | Priebe.Amanda@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Paul Friedman, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| 6-Lead AI-ECG | Diagnostic Test | A 6-lead ECG uses six electrodes placed on the chest and limbs to record the heart's electrical activity from multiple perspectives. |
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| 12-Lead AI-ECG | Diagnostic Test | 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. |
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The number of positive AI-ECG results for HCM will be based on how many patient ECGs indicate a possible diagnosis of HCM |
| 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 | 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. | 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. | 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. | 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. | 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. | 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. | Baseline |