๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria (Proband)
* Male or female age โฅ 18 years
* Confirmed diagnosis of non-ischemic DCM determined at the discretion of the treating physician and defined as LVEF โค 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 โฅ 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 โฅ75% stenosis of either left main or Left Anterior Descending (LAD) or โฅ75% 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
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What it tests
- Mobile 6L AI-EKG Screening
Lancaster General Hospital
Lancaster, United States
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.