Dilated Cardiomyopathy Detection Using AI and Screening With Mobile Technology (DCM-DETECT)

NCT06688396 | Recruiting FDA Device

• 1 other identifier: 855484
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dilated Cardiomyopathy; Heart Failure; Heart Disease

Keywords

Dilated Cardiomyopathy; Heart Failure; Heart Disease

Outcome Measures

Primary Outcomes (1)

• 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.

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.

  Assessed at time of EKG results. About 2 weeks post collection.

Other Outcomes (3)

• 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

  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.

Study Arms (1)

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.

Device: Mobile 6L AI-EKG Screening

Interventions

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.

DCM Screening

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Lancaster General Hospital: lead
• Mayo Clinic: collaborator

Study Sites (1)

Lancaster General Hospital

Lancaster, Pennsylvania, 17602, United States

RECRUITING

Related Links

• 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

MeSH Terms

Conditions

Cardiomyopathy, Dilated; Heart Failure; Heart Diseases

Condition Hierarchy (Ancestors)

Cardiomegaly; Cardiovascular Diseases; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Roy Small, MD

  Penn Medicine / Lancaster General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Halle Becker, MPH

CONTACT

717-544-1777; Halle.Becker@pennmedicine.upenn.edu

Jonathan Derr, MBA

CONTACT

717-544-1777; Jonathan.Derr@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 14, 2024
• Study Start: December 4, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)