Dilated Cardiomyopathy Detection Using AI and Screening With Mobile Technology (DCM-DETECT)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLancaster General Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Mobile 6L AI-EKG Screening
DeviceParticipants (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.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: DCM ScreeningExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
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.
Time frame
Assessed at time of EKG results. About 2 weeks post collection.Other outcomes
1
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.
Time frame
Assessed at time of decline and survey completion, about 30 minutes.2
Positive cardiac screening procedures /total number of FDR undergoing cardiac screening procedures
Time frame
Assessed at 3 months post enrollment check-in or 6 months post enrollment check-in if not completed by 3 months.3
Comparison of AI EKG reduced LVEF algorithm results between 6L Kardia EKG and 12L AI EKG, if available, in DCM probands.
Time frame
Assessed during data analysis, 2 years after study start.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Lancaster General Hospital
Lead sponsor
Mayo Clinic
Collaborator
Source ClinicalTrials.gov