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| Name | Class |
|---|---|
| Mayo Clinic | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile 6L AI-EKG Screening | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessed for a minimum of 3 months post enrollment up to 6 months post enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| Positive AI-EKG screens among FDR of DCM probands (LVEF ≤ 45%)/total population of the FDR of DCM probands undergoing AI-EKG. | Assessed at time of EKG results. About 2 weeks post collection. |
| Measure | Description | Time Frame |
|---|---|---|
| Responses to decliner survey questions addressing barriers to adoption of AI technology, variables that contribute to the reluctance to participate, and logistical barriers to research. surveys. | Assessed at time of decline and survey completion, about 30 minutes. | |
| Positive cardiac screening procedures /total number of FDR undergoing cardiac screening procedures |
Inclusion Criteria (Proband)
Inclusion Criteria (FDR)
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
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)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Halle Becker, MPH | Contact | 717-544-1777 | Halle.Becker@pennmedicine.upenn.edu | |
| Jonathan Derr, MBA | Contact | 717-544-1777 | Jonathan.Derr@pennmedicine.upenn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Roy Small, MD | Penn Medicine / Lancaster General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lancaster General Hospital | Recruiting | Lancaster | Pennsylvania | 17602 | United States |
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| Label | URL |
|---|---|
| Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD). | View source |
| Investigational Device Exemptions | View source |
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| ID | Term |
|---|---|
| D002311 | Cardiomyopathy, Dilated |
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D006332 | Cardiomegaly |
| D002318 | Cardiovascular Diseases |
| D009202 | Cardiomyopathies |
| D000083083 | Laminopathies |
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| Assessed at 3 months post enrollment check-in or 6 months post enrollment check-in if not completed by 3 months. |
| Comparison of AI EKG reduced LVEF algorithm results between 6L Kardia EKG and 12L AI EKG, if available, in DCM probands. | Assessed during data analysis, 2 years after study start. |
| Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors | View source |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |