Featured Clinical Trial
NYU Winthrop Hospital’s Division of Cardiology has taken the lead on a new and exciting multicenter international trial entitled “The Non-Ischemic Cardiomyopathy (NICM) Registry”.
Dr. Juan Gaztanaga, Director – NYU Winthrop’s Advanced Cardiac Imaging is the principal investigator working with a coordinating committee consisting of world renown cardiologists. The coordinating committee is made up of Dr. Naveen Pereira from The Mayo Clinic, Drs. Heather Ross and Michael Farkouh from the Peter Munk Cardiac Centre at University of Toronto and Dr. Juan Gaztanaga. NYU Winthrop Hospital serves as both coordinating center and core laboratory.
The initial phase of the registry includes 11 institutions from three countries – Canada, Spain and the United States (US). In the United States, NYU Winthrop Hospital is the lead center under Dr. Juan Gaztanaga, along with The Mayo Clinic located in Rochester, Minnesota. Toronto University will oversee all Canadian activities. In Spain, Universidad De Leon is taking Charge with European - leader Dr. David Alonso along with Universidad de Salamanca, Universidad de Oviedo and Hospital Universertario de la Princesa in Madrid.
The Non-Ischemic Cardiomyopathy (NICM) Registry Details:
We are doing research on a heart condition called non-ischemic cardiomyopathy (NICM) with an ejection fraction (EF) <40%. (Non ischemic means that a condition is not caused by lack of oxygen to a muscle, in this case the heart, due to the blockage of a heart artery. Cardiomyopathy is a disease that weakens, enlarges or thickens your heart muscle making it harder for your heart to pump blood which can lead to heart failure. An (EF) ejection fraction is a measure of how well your heart forces or pumps blood out to the rest of your body. This is an indicator of your heart health. These two conditions, non-ischemic cardiomyopathy and lower ejection fraction, are indicators of risk for more severe cardiac events. These events could include fast, irregular and potentially deadly heartbeats, which are routinely treated with an implantable defibrillator (ICD) usually after a failed 3 to 6 month trial of optimal medications to see if the heart function improves.
Our study is designed to look at individuals with a recent diagnosis of NICM and EF of <40% who have had, at the request of their doctor, a cardiac MRI (CMR). It is a 3-year observational study looking at patients who are newly diagnosed with NICM and EF <40%. There is no intervention or treatment other than routine care and observation. A participant’s health status is observed after the cardiac MRI every six months for up to 3 years. It is hoped that by following participants, the investigators will be able to develop a tool that further advances how patients are evaluated for risk of sudden death and to better define the correct treatment.
A total of 1,950 participants are expected to be enrolled into the study at NYU Winthrop Hospital and a number of national and international centers. NYU Winthrop Hospital plans to enroll up to 100 participants over the course of up to three years.