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Recruiting NCT07351656

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

No phase Interventional Heart Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Focused Cardiac Ultrasound, 6-Lead AI-ECG, 12-Lead AI-ECG.
Who it may be relevant to
Registry conditions: Heart Disease. Basic parameters: from 15 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Screening for Heart Disease Using AI-Enabled Electrocardiography and Focused Cardiac Ultrasound: the AI CVD Screen Study.

Overview

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 test Focused Cardiac Ultrasound
    Focused cardiac ultrasound will utilize sonography to evaluate specific cardiac conditions, such as ventricular function, pericardial effusion, and valvular abnormalities.
  • Diagnostic test 6-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 test 12-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.

Primary outcome measures

  • Percentage of participants with positive AI-ECG findings confirmed by echocardiography (Adolescents and young adults) [Time frame: Baseline]
  • Number of patients with positive AI-ECG detection for left-right sided SHD (Community Dwelling Adults) [Time frame: Baseline]
  • Number of times the AI-ECG provides a correct diagnosis of clinically significant cardiac disease (Pregnant women) [Time frame: Baseline]
Secondary outcome measures (9)
  • Number of false positive AI-ECG Results (Adolescents and young adults) [Time frame: Baseline]
  • Number of positive AI-ECG results for hypertrophic cardiomyopathy (HCM) (Adolescents and young adults) [Time frame: Baseline]
  • Number of positive AI-ECG results for congenital heart defect (CHD) (Adolescents and young adults) [Time frame: Baseline]
  • Proportion of patients by age group to receive a diagnosis (Community Dwelling Adults) [Time frame: Baseline]
  • Proportion of total patients to receive a diagnosis based on screening with 6 lead ECG (Community Dwelling Adults) [Time frame: Baseline]
  • Proportion of total patients to receive a diagnosis based on screening with 12 lead ECG (Community Dwelling Adults) [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) [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) [Time frame: Baseline]
  • Number of non-cardiac adverse events (Pregnant Women) [Time frame: Baseline]

Eligibility criteria

Adolescents and young adults:

Inclusion criteria

  • Enrollment in a high-school, college or a resident in MN during the study period
  • Age 15-29 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+))

Exclusion criteria

  • Inability to provide informed consent to participate in the study

Pregnant women:

Inclusion criteria

  • Adult female aged 18 to 49 years
  • Pregnant at the time of enrollment
  • Receiving obstetric care at identified study site(s)
  • Willing and able to provide informed consent

Exclusion criteria

  • Inability to provide consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT07351656 · 25-012252

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗