CardiomyopathyNCT06609174
AI-SCREENDCM Decentralized Clinical Trial - Pilot Study
A study testing KardiaRx ECG Screening and AI interpretation of ECG in people with Cardiomyopathy, run by Mayo Clinic at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiomyopathy
- What is being tested?
- KardiaRx ECG Screening and AI interpretation of ECG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2024to 26 Sep 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 peripartum cardiomyopathy, 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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.
- Conditions
- Cardiomyopathy
- Being tested
- KardiaRx ECG Screening and AI interpretation of ECG
- Keywords
- Artificial Intelligence
- Medical subject headings
- Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KardiaRx ECG Screening and AI interpretation of ECGDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| First degree relatives | Experimental | Subjects who are first-degree relatives of patients with DCM Receives: Diagnostic Test: KardiaRx ECG Screening and AI interpretation of ECG |
| DCM (Dilated Cardiomyopathy) Patients | Experimental | Subjects who are diagnosed with DCM (dilated cardiomyopathy). Receives: Diagnostic Test: KardiaRx ECG Screening and AI interpretation of ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of First-Degree Relatives to Complete the AI-ECG
Measured by the number of subjects who had a complete transmission from the Kardia 6-lead device to the AI-ECG algorithm.
Measured: Baseline
Number of First-Degree Relatives to Complete Cardiac Screening
The number of subjects who completed cardiac screening (i.e. had a scheduled or Completed TTE or had a scheduled or completed clinician visit for the purposes of generating a cardiac evaluation).
Measured: Baseline
Secondary outcomes (1)
Number of Subjects With an AI ECG-Predicted Left Ventricular Ejection Fraction ≤45%
Number of participants with a positive AI-ECG result, defined as an AI-predicted left ventricular ejection fraction (LVEF) of 45% or less. ECGs were obtained using the AliveCor Kardia 6L device and analyzed using FDA-cleared AI software designed to detect reduced LVEF (≤45%).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start18 Oct 2024
- Primary completion26 Sep 2025
- Study completion26 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naveen L. Pereira, Mayo Clinic
- Investigators
- Naveen Pereira, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609174
- Sponsor's protocol ID
- 24-006256
- Status last verified
- Sep 2026
- First submitted
- 20 Sep 2024
- Last updated
- 13 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No