NCT06688396 · Lancaster General Hospital
Dilated Cardiomyopathy Detection Using AI and Screening With Mobile Technology (DCM-DETECT)
(DCM-DETECT)
What this study is about
This is a forward-looking, single-treatment group$1 clinical trial in which participants with dilated cardiomyopathy will invite their first degree relatives to undergo mobile cardiac, electrocardiogram screening.
View original scientific description
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.
Interventions
DEVICE
Mobile 6L AI-EKG Screening
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.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 Inclusion Criteria (FDR)
- 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
Exclusion criteria
- 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 Exclusion Criteria (FDR)
- 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
Where
- Lancaster, Pennsylvania
Collaborators
Mayo Clinic
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 30, 2025 · Source of record for eligibility and locations