Dilated Cardiomyopathy Detection Using AI and Screening With Mobile Technology (DCM-DETECT)

Summary

This is a prospective, single-arm clinical trial in which participants with dilated cardiomyopathy will invite their first degree relatives to undergo mobile cardiac, electrocardiogram screening.

Eligibility

Inclusion Criteria (Proband)

* Male or female age ≥ 18 years
* Confirmed diagnosis of non-ischemic 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 adult 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 verbal 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 (ST-Elevation Myocardial Infarction), NSTEMI (Non-ST-Elevation Myocardial Infarction) or unstable angina) revascularization or ≥75% stenosis of either left main or Left Anterior Descending (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

Exclusion Criteria (FDR)

* Previously informed about cardiac screening or has completed cardiac screening by transthoracic echocardiogram (TTE)
* Previously diagnosed with reduced LVEF
* (CPC Participants only) Home address outside of traveling range

Conditions3

Locations1 site

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