Decrease (-) Restore Default Increase (+)

Clinical Trials

Topic   Cardiology
Title   Development of an Evidenced-Based Tool for Prediction of Sudden Death in Patients with Non-Ischemic Cardiomyopathy - (NICM Registry)
Summary   A multi-site, observational (meaning no research treatment) registry for patients newly diagnosed with non-ischemic cardiomyopathy (NICM) who have a reduced ejection fraction (EF), < 40% (less than or equal to 40%) on echocardiogram and cardiac MRI. The purpose of the study is to collect data that can be used to improve current treatment guidelines for the use of Implanted defibrillators (ICD) in patients with NICM. Patients are followed over a two-year period, with phone call updates and outpatient medical record review every six months.
Description   Cardiomyopathy refers to diseases of the heart muscle which cause the heart to become weaker. There are many different causes of cardiomyopathy. This study is looking at patients with cardiomyopathy that is not due to a reduced blood supply to the heart muscle. Reduced blood supply is called “ischemic,” so this study is looking at patients with “non-ischemic” cardiomyopathy (NICM). Ejection fraction (EF) is the amount of blood leaving the heart each time it contracts. EF is a measure of the strength, or how well the heart pumps with each beat and it is measured on tests such as echocardiogram (ultrasound) and cardiac magnetic resonance imaging (CMR). Patients newly diagnosed with NICM who have a reduced ejection fraction (EF) of less than or equal to 40% may be eligible for this study. Patients with NICM are at increased risk for hospitalizations due to congestive heart failure, abnormal heart rhythms and are also at an increased risk of sudden cardiac death. An implanted device, called an implantable cardioverter defibrillator (ICD) is often used to reduce the risk of sudden death for patients with NICM. An ICD uses electrical pulses or shocks to help control life-threatening arrhythmias, especially those that can cause sudden cardiac arrest. There are also risks associated with ICDs including possible unnecessary pulses or shocks and risks related to the surgery used to place the device. The researchers would like to observe patients newly diagnosed with NICM and follow them over time to collect data that can be used to improve guidelines for the use of ICDs in patients with NICM.
IRB Number   14305
Inclusion/Notes   Patients newly diagnosed with NICM who have a reduced ejection fraction (EF) of <40% may be eligible for this study.
Principal Name   Juan Gaztanaga, MD
Contact Name   Wendy Drewes, BSN, RN, CCRC (wdrewes@nyuwinthrop.org)
Email   jgaztanaga@nyuwinthrop.org
Phone   516-663-4481
Alternate Phone   516-663-2929