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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First degree relatives | Experimental | Subjects who are first-degree relatives of patients with DCM |
|
| DCM (Dilated Cardiomyopathy) Patients | Experimental | Subjects who are diagnosed with DCM (dilated cardiomyopathy). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KardiaRx ECG Screening and AI interpretation of ECG | Diagnostic Test | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of First-Degree Relatives to complete the AI-ECG | Measured by the number of complete transmissions from the Kardia 6-lead device to the AI-ECG algorithm. | Baseline |
| Number of First-Degree relatives to complete cardiac screening | The following screening procedures will be considered a valid cardiac screening attempt:
| Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with an Left Ventricular Ejection Fraction ≤ 45% | Left Ventricular Ejection Fraction will be determined by AI-ECG | Baseline |
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Inclusion Criteria (Proband)
Inclusion Criteria (FDR)
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
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
Exclusion Criteria (FDR)
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| Name | Affiliation | Role |
|---|---|---|
| Naveen Pereira, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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