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OpenTrials
Completed

NCT Number: NCT06609174

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Number of First-Degree Relatives to complete the AI-ECG

    Time frame: Baseline

    Measured by the number of complete transmissions from the Kardia 6-lead device to the AI-ECG algorithm.

  2. Number of First-Degree relatives to complete cardiac screening

    Time frame: Baseline

    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

Secondary outcomes

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

    Time frame: Baseline

    Left Ventricular Ejection Fraction will be determined by AI-ECG

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 24, 2024
Registry last updated
Nov 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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