AI-SCREENDCM Decentralized Clinical Trial - Pilot Study

Artificial Intelligence Electrocardiogram Enabled Mobile Device in Screening Families for Dilated Cardiomyopathy (The AI-SCREENDCM Decentralized Clinical Trial Pilot Study)

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.

Study Overview

• Status: Completed
• Conditions: Cardiomyopathy
• Intervention / Treatment: Diagnostic test: KardiaRx ECG Screening and AI interpretation of ECG

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: First degree relatives; Subjects who are first-degree relatives of patients with DCM	Diagnostic test: 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
Experimental: DCM (Dilated Cardiomyopathy) Patients; Subjects who are diagnosed with DCM (dilated cardiomyopathy).	Diagnostic test: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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: Scheduled or Completed TTE; Scheduled or completed clinician visit for the purposes of generating a cardiac evaluation	Baseline

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Naveen Pereira, M.D., Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2024
• Primary Completion (Actual): September 26, 2025
• Study Completion (Actual): September 26, 2025

Study Registration Dates

• First Submitted: September 20, 2024
• First Submitted That Met QC Criteria: September 20, 2024
• First Posted (Actual): September 24, 2024

Study Record Updates

• Last Update Posted (Estimated): November 4, 2025
• Last Update Submitted That Met QC Criteria: November 3, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Artificial Intelligence
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Cardiomyopathies
• Other Study ID Numbers: 24-006256

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes