AI-SCREENDCM Decentralized Clinical Trial - Pilot Study

Mayo Clinic

Status: Completed

Conditions: Cardiomyopathy

Treatments: Diagnostic Test: KardiaRx ECG Screening and AI interpretation of ECG

Study type: Interventional

Funder types: Other

Identifiers

NCT06609174

24-006256

Details and patient eligibility

About

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.

Enrollment: 119 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Exclusion Criteria (FDR)

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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119 participants in 2 patient groups

First degree relatives

Experimental group

Description:

Subjects who are first-degree relatives of patients with DCM

Treatment:

Diagnostic Test: KardiaRx ECG Screening and AI interpretation of ECG

DCM (Dilated Cardiomyopathy) Patients

Experimental group

Description:

Subjects who are diagnosed with DCM (dilated cardiomyopathy).

Treatment:

Diagnostic Test: KardiaRx ECG Screening and AI interpretation of ECG