AI-SCREENDCM Decentralized Clinical Trial - Pilot Study

NCT06609174 | Completed FDA Device

• 1 other identifier: 24-006256
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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

Keywords

Artificial Intelligence

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Number of subjects with an Left Ventricular Ejection Fraction ≤ 45%

  Baseline

Study Arms (2)

First degree relatives

EXPERIMENTAL

Subjects who are first-degree relatives of patients with DCM

Diagnostic Test: KardiaRx ECG Screening and AI interpretation of ECG

DCM (Dilated Cardiomyopathy) Patients

EXPERIMENTAL

Subjects who are diagnosed with DCM (dilated cardiomyopathy).

Diagnostic Test: KardiaRx ECG Screening and AI interpretation of ECG

Interventions

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

DCM (Dilated Cardiomyopathy) Patients; First degree relatives

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Naveen Pereira, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 24, 2024
• Study Start: October 18, 2024
• Primary Completion: September 26, 2025
• Study Completion: September 26, 2025
• Last Updated: November 4, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)