Cardiomyopathy
Conditions
Keywords
Artificial Intelligence
Brief summary
The purpose of this study is to assess the feasibility and impact of screening FDR of DCM probands using a mobile ECG with the ability to transmit the ECG for cloud-based AI analysis to detect reduced left ventricular ejection fraction (LVEF). This protocol will examine the impact of incorporating the screening AI enhanced ECG into standard of care recommendations.
Interventions
DIAGNOSTIC_TESTKardiaRx ECG Screening and AI interpretation of ECG
The Kardia 6-lead device is an ambulatory, wireless device that connects to a smartphone. The KardiaRx App processes the signal acquired from the Kardia device into a real-time ECG. ECG will be interpreted by an AI algorithm
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(Proband) * Male or female age ≥ 18 years * Confirmed diagnosis of DCM determined at the discretion of the treating physician and defined as LVEF ≤ 45% at any time during the clinical course of the patient * Must have at least one living ≥ 18 years FDR * Able to provide informed consent Inclusion Criteria (FDR) * Male or female age ≥ 18 years who are first-degree relatives of patients with DCM * Proband has provided informed consent * FDR able to provide informed consent * Access to a smartphone or digital tablet with cellular data or Wi-Fi access
Exclusion criteria
(Proband) * DCM attributed to any other secondary form of cardiomyopathy per the investigator's determination * Proband has previously informed FDR to undergo cardiac screening * Ischemic cause of reduced LVEF * evidence of myocardial infarction, inducible ischemia or chest pain on stress testing in absence of coronary angiogram to rule out ischemic disease * history of acute coronary syndromes (STEMI, NSTEMI or unstable angina) revascularization or ≥75% stenosis of either left main or LAD or ≥75% stenosis of 2 major epicardial vessels on angiogram * Moderate or greater primary valvular abnormality not due to underlying cardiomyopathy * Congenital structural heart disease * Severe and untreated or untreatable hypertension * Cardiomyopathy due to acute or reversible conditions; examples include tachyarrhythmias, thyroid disorders, iron overload * Any secondary cause of reduced LVEF such as pregnancy, myocarditis, amyloidosis, sarcoidosis, exposure to toxins including alcohol, substance abuse or chemotherapeutic drug * (CPC Participants only) Home address outside of traveling range
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of First-Degree Relatives to complete the AI-ECG | Baseline | Measured by the number of complete transmissions from the Kardia 6-lead device to the AI-ECG algorithm. |
| Number of First-Degree relatives to complete cardiac screening | Baseline | The following screening procedures will be considered a valid cardiac screening attempt: * Scheduled or Completed TTE * Scheduled or completed clinician visit for the purposes of generating a cardiac evaluation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with an Left Ventricular Ejection Fraction ≤ 45% | Baseline | Left Ventricular Ejection Fraction will be determined by AI-ECG |
Countries
United States
Outcome results
None listed