Health TrialsbyHealthPanel

A Study Of Heart Disease Using AI-Enabled Electrocardiography And Focused Cardiac Ultrasound

ConditionHeart Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Presence of a pacemaker or defibrillator

Inability to obtain a quality ECG tracing

Adult female aged 18 to 49 years

Pregnant at the time of enrollment

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

Treatment groups

19,300 Participants
are divided into 3 treatment groups
Group A: Community dwelling adultsExperimental treatment 3 interventions
Group B: Pregnant womenExperimental treatment 3 interventions
Group C: Adolescents and young adultsExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline
2

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
3

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

Secondary outcomes

1

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
2

Number of positive AI-ECG results for hypertrophic cardiomyopathy (HCM) (Adolescents and young adults)

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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