Dilated CardiomyopathyDCM-DETECTNCT06688396
Dilated Cardiomyopathy Detection Using AI and Screening With Mobile Technology (DCM-DETECT)
A study testing Mobile 6L AI-EKG Screening in people with Dilated Cardiomyopathy and Heart Failure, run by Lancaster General Hospital at 1 site in United States.
Trial summary
This is a prospective, single-arm clinical trial in which participants with dilated cardiomyopathy will invite their first degree relatives to undergo mobile cardiac, electrocardiogram screening. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dilated Cardiomyopathy, Heart Failure, Heart Disease
- What is being tested?
- Mobile 6L AI-EKG Screening
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female age ≥ 18 years
- 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
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 (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
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 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Lancaster General Hospital
Lancaster, Pennsylvania, 17602
Halle Becker, MPH, 717-544-1777, Halle.Becker@pennmedicine.upenn.edu
Jonathan Derr, MBA, 717-544-1777, jonathan.derr@pennmedicine.upenn.edu
About this study
Official title: Dilated Cardiomyopathy Detection Using Artificial Intelligence and Screening With Mobile Technology
This is a prospective, single-arm clinical trial in which participants with dilated cardiomyopathy will invite their first degree relatives to undergo mobile cardiac, electrocardiogram screening.
Read the detailed description
The purpose of this study is to examine the impact of an "Artificial Intelligent" (AI) enhanced 6Lead (6L) mobile electrocardiogram (EKG) in encouraging first degree relatives (FDR) of probands with a dilated cardiomyopathy (DCM) to obtain appropriate cardiac screening.
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
- Dilated Cardiomyopathy, Heart Failure, Heart Disease
- Being tested
- Mobile 6L AI-EKG Screening
- Keywords
- Dilated Cardiomyopathy, Heart Failure, Heart Disease
- Medical subject headings
- Cardiomyopathy, Dilated, Heart Failure, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile 6L AI-EKG ScreeningDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| DCM Screening | Experimental | 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. Receives: Device: Mobile 6L AI-EKG Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
This study's primary endpoint is to assess the feasibility of performing AI-EKG test and the subsequent uptake of cardiac screening in FDR of DCM patients.
The number of consented FDR who successfully undergo AI-EKG and subsequent recommended cardiac follow up.
Measured: Assessed for a minimum of 3 months post enrollment up to 6 months post enrollment.
Secondary outcomes (1)
Positive AI-EKG screens among FDR of DCM probands (LVEF ≤ 45%)/total population of the FDR of DCM probands undergoing AI-EKG.
Measured: Assessed at time of EKG results. About 2 weeks post collection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start4 Dec 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dilated CardiomyopathyStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lancaster General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic
- Responsible party
- Sponsor
- Investigators
- Roy Small, MD, Principal investigator, Penn Medicine / Lancaster General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06688396
- Sponsor's protocol ID
- 855484
- Acronym
- DCM-DETECT
- Status last verified
- Jan 2025
- First submitted
- 12 Nov 2024
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dilated Cardiomyopathy Detection Using Artificial Intelligence and Screening With Mobile Technology
- ClinicalTrials.gov ID
- NCT06688396
- Acronym / sponsor ID
- DCM-DETECT / 855484
- Conditions
- Dilated Cardiomyopathy, Heart Failure, Heart Disease
- Keywords
- Dilated Cardiomyopathy, Heart Failure, Heart Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Lancaster General HospitalUniversity, hospital or other
- Collaborators
- Mayo Clinic
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, single-arm clinical trial in which participants with dilated cardiomyopathy will invite their first degree relatives to undergo mobile cardiac, electrocardiogram screening.
Detailed description
The purpose of this study is to examine the impact of an "Artificial Intelligent" (AI) enhanced 6Lead (6L) mobile electrocardiogram (EKG) in encouraging first degree relatives (FDR) of probands with a dilated cardiomyopathy (DCM) to obtain appropriate cardiac screening.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DCM Screening | Experimental | Device: Mobile 6L AI-EKG ScreeningParticipants (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female age ≥ 18 years
- 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
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 |
|---|---|---|
| Mobile 6L AI-EKG ScreeningParticipants (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. | Device | DCM Screening |
Primary outcome
This study's primary endpoint is to assess the feasibility of performing AI-EKG test and the subsequent uptake of cardiac screening in FDR of DCM patients.
Time frame: Assessed for a minimum of 3 months post enrollment up to 6 months post enrollment.
The number of consented FDR who successfully undergo AI-EKG and subsequent recommended cardiac follow up.
1 secondary outcome
Positive AI-EKG screens among FDR of DCM probands (LVEF ≤ 45%)/total population of the FDR of DCM probands undergoing AI-EKG.
Time frame: Assessed at time of EKG results. About 2 weeks post collection.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD).Link provided by the sponsor.
- Investigational Device ExemptionsLink provided by the sponsor.
- Information Sheet Guidance for IRBs, Clinical Investigators, and SponsorsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Roy Small, MD principal investigator
Penn Medicine / Lancaster General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile 6L AI-EKG Screening in people with Dilated Cardiomyopathy and Heart Failure, run by Lancaster General Hospital 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: looking for participants now, as of the sponsor's last update on 30 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Halle Becker, MPH (717-544-1777, Halle.Becker@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
This study's primary endpoint is to assess the feasibility of performing AI-EKG test and the subsequent uptake of cardiac screening in FDR of DCM patients. (time frame: Assessed for a minimum of 3 months post enrollment up to 6 months post enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2025.