AI-SCREENDCM Decentralized Clinical Trial - Pilot Study

NCT ID: NCT06609174

Last Updated: 2025-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-18
• Study Completion Date: 2025-09-26

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.

Conditions

Cardiomyopathy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

First degree relatives

Subjects who are first-degree relatives of patients with DCM

Group Type: EXPERIMENTAL

KardiaRx ECG Screening and AI interpretation of ECG

Intervention Type: 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

DCM (Dilated Cardiomyopathy) Patients

Subjects who are diagnosed with DCM (dilated cardiomyopathy).

Group Type: EXPERIMENTAL

KardiaRx ECG Screening and AI interpretation of ECG

Intervention Type: 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

Interventions

KardiaRx 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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Naveen L. Pereira

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Naveen Pereira, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

24-006256

Identifier Type: -

Identifier Source: org_study_id