Dilated Cardiomyopathy Detection Using AI and Screening With Mobile Technology (DCM-DETECT)
NCT ID: NCT06688396
Last Updated: 2025-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2024-12-04
2026-12-31
Brief Summary
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Detailed Description
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The AI enhanced EKG (AI-EKG) will be acquired using the AliveCor KardiaMobile 6L system which allows the generation of prediction probabilities for reduced left ventricular function (LVEF). The AliveCor KardiaMobile 6L device is an FDA approved handheld smart device that records an EKG in 30 seconds to 5-minute increments. The device is an ambulatory wireless device that connects to a smartphone and is easy to use. The EKG signal is communicated wirelessly via Bluetooth to a mobile computing platform (MCP) which can be a smartphone or tablet. The MCP will be running either the KardiaRx mobile application if the participant is remote, or the KardiaStation App if the participation is on sight at either the Lancaster General Hospital (LGH) campus or the Central Pennsylvania Clinic (CPC) location. The 6L EKG is transmitted following processing by the Kardia Apps. The results of the EKG tracings recorded by the AliveCor devices will not be entered into the electronic medical record or used to guide clinical care. The EKG data from the recordings identified only by the connection code will be uploaded to the AliveCor cloud for proprietary AI analysis designed to detect impaired LVEF. This AI software for LVEF analysis is FDA approved.
All participating FDR will be encouraged to pursue cardiac screening per American College of Cardiology/American Heart Association (ACC/AHA) recommendations.
If available, the probands clinical 12Lead (12L) EKGs will be obtained if recorded within 30 days of their Kardia 6L recording. The concordance of the algorithm results applied to the Kardia 6L data with the 12L FDA approved LVEF algorithm results will be assessed.
Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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DCM Screening
Participants (probands) with dilated cardiomyopathy (DCM) will invite their first-degree relatives (FDR) to participate in DCM screening to examine the impact of an "Artificial Intelligent" (AI) enhanced 6lead (6L) mobile electrocardiogram (EKG) in encouraging FDR of probands with a DCM to obtain appropriate cardiac screening.
Mobile 6L AI-EKG Screening
Participants (probands) with DCM will invite their first-degree relatives to undergo DCM screening procedures.
Probands and first-degree relatives will complete a mobile 6L AI-EKG which will be transmitted to a mobile app and interpreted by the AI-EKG algorithm. Results will be shared electronically or verbally to the participant.
If available, the probands clinical 12L EKGs will be obtained if recorded within 30 days of their Kardia 6L recording.
All participating FDR will be encouraged to pursue cardiac screening per ACC/AHA recommendations. Study staff will obtain echocardiogram results up to 6 months of participant enrollment.
Interventions
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Mobile 6L AI-EKG Screening
Participants (probands) with DCM will invite their first-degree relatives to undergo DCM screening procedures.
Probands and first-degree relatives will complete a mobile 6L AI-EKG which will be transmitted to a mobile app and interpreted by the AI-EKG algorithm. Results will be shared electronically or verbally to the participant.
If available, the probands clinical 12L EKGs will be obtained if recorded within 30 days of their Kardia 6L recording.
All participating FDR will be encouraged to pursue cardiac screening per ACC/AHA recommendations. Study staff will obtain echocardiogram results up to 6 months of participant enrollment.
Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of non-ischemic 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 adult 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 verbal consent
* Access to a smartphone or digital tablet with cellular data or Wi-Fi access
Exclusion Criteria
* 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 (ST-Elevation Myocardial Infarction), NSTEMI (Non-ST-Elevation Myocardial Infarction) or unstable angina) revascularization or ≥75% stenosis of either left main or Left Anterior Descending (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 transthoracic echocardiogram (TTE)
* Previously diagnosed with reduced LVEF
* (CPC Participants only) Home address outside of traveling range
18 Years
ALL
Yes
Sponsors
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Mayo Clinic
OTHER
Lancaster General Hospital
OTHER
Responsible Party
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Principal Investigators
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Roy Small, MD
Role: PRINCIPAL_INVESTIGATOR
Penn Medicine / Lancaster General Hospital
Locations
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Lancaster General Hospital
Lancaster, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD).
Investigational Device Exemptions
Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors
Other Identifiers
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855484
Identifier Type: -
Identifier Source: org_study_id
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