Dilated Cardiomyopathy Detection Using AI and Screening With Mobile Technology (DCM-DETECT)
Recruiting · NCT06688396 · Interventional (participants receive a specific treatment) · Lead sponsor: Lancaster General Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Mobile 6L AI-EKG Screening
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Proband)
- 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
- 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
- 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 it is running
1 location listed across 1 US state.
- Lancaster General Hospital - Lancaster, Pennsylvania, United States