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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Show all 14Show fewer

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

Other trials in United States

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)

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 groups in NCT06609174
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.

18 Oct 202426 Sep 2025

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Artificial Intelligence Electrocardiogram Enabled Mobile Device in Screening Families for Dilated Cardiomyopathy (The AI-SCREENDCM Decentralized Clinical Trial Pilot Study)
ClinicalTrials.gov ID: NCT06609174
Acronym / sponsor ID: 24-006256
Conditions: Cardiomyopathy
Keywords: Artificial Intelligence
Study type: Interventional
Recruitment status: Completed
Enrolment: 119 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Study start: 18 Oct 2024 (actual)
Primary completion: 26 Sep 2025 (actual)
Study completion: 26 Sep 2025 (actual)
First posted: 24 Sep 2024 (actual)
Results: Posted 13 Oct 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Screening
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
First degree relatives	Experimental	Diagnostic Test: KardiaRx ECG Screening and AI interpretation of ECGSubjects who are first-degree relatives of patients with DCM
DCM (Dilated Cardiomyopathy) Patients	Experimental	Diagnostic Test: KardiaRx ECG Screening and AI interpretation of ECGSubjects who are diagnosed with DCM (dilated cardiomyopathy).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (14 listed)

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
Moderate or greater primary valvular abnormality not due to underlying cardiomyopathy
Congenital structural heart disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
KardiaRx ECG Screening and AI interpretation of ECGThe 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	Diagnostic test	DCM (Dilated Cardiomyopathy) Patients, First degree relatives

Primary outcome

Number of First-Degree Relatives to Complete the AI-ECG
Time frame: Baseline
Measured by the number of subjects who had a complete transmission from the Kardia 6-lead device to the AI-ECG algorithm.
Number of First-Degree Relatives to Complete Cardiac Screening
Time frame: Baseline
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).

1 secondary outcome

Number of Subjects With an AI ECG-Predicted Left Ventricular Ejection Fraction ≤45%
Time frame: Baseline

Results and safety

Results posted to the registry on 13 Oct 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
First Degree Relatives	66	58
DCM (Dilated Cardiomyopathy) Patients	47	47

Primary outcome: Number of First-Degree Relatives to Complete the AI-ECG

Time frame: Baseline. Count of participants. Unit: Participants

Measure	First Degree Relatives n = 66	DCM (Dilated Cardiomyopathy) Patients n = 0
Value	58	–

Population analysed: This outcome measure only pertained to the First degree relatives arm, therefore no data was collected and no data exists for this outcome measure for the subjects in the DCM arm.

Primary outcome: Number of First-Degree Relatives to Complete Cardiac Screening

Time frame: Baseline. Count of participants. Unit: Participants

Measure	First Degree Relatives n = 49	DCM (Dilated Cardiomyopathy) Patients n = 0
Value	14	–

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected from the time of informed consent through study completion, approximately 2 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
First Degree Relatives	0 of 66 (0%)	0 of 66 (0%)	0 of 66
DCM (Dilated Cardiomyopathy) Patients	0 of 47 (0%)	0 of 47 (0%)	0 of 47

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Not yet recruitingObservational study
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RecruitingObservational study
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Recruiting
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Myocardial Infarction (MI), Sudden Cardiac Death Due to Cardiac Arrhythmia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Naveen Pereira, M.D. principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of First-Degree Relatives to Complete the AI-ECG (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06609174.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.