For Physicians

The Cardiovascular News Beat

August 2009

Cardiovascular Research

The prominent cardiovascular research conducted at the Heart
Center at Newark Beth Israel Medical Center helps patients gain access to promising new treatments and technologies. Our researchers participate in industry sponsored and investigator initiated clinical trials that encompass general and interventional cardiology, electrophysiology, heart failure, heart transplant, cardiac surgery and ventricular assist devices. The entire team works closely to incorporate research findings into the comprehensive care to improve patient outcomes.

Newark Beth Israel remains one of the leading enrolling centers for the nationwide HeartMate II LVAS trial that is evaluating the device as a bridge to transplant and as destination therapy. The results of the TIC-TAC trial initiated by David Baran, MD, Director of Heart Failure and Transplant Research, is making news world-wide regarding immunosuppressive therapy in heart transplant recipients.

Currently Enrolling Trials

ACORN GEN-2 Clinical evaluation of cardiac support device: a feasibility trial protocol; Principal Investigator: Margarita Camacho, MD

ACORN-MVR Clinical evaluation of Acorn Cardiac Support Device Therapy in patients with dilated cardiomyopathy— A confirmatory trial; Principal Investigator: Margarita Camacho, MD

ASCEND-HF Double-blind, placebocontrolled, multi-center acute study of clinical effectiveness of Nesiritide in subjects with decompensated heart failure; Principal Investigator: David Baran, MD

ATOLL STUDY Acute STEMI treated with primary angioplasty and intravenous enoxaparin or unfractionated heparin to lower ischemia and bleeding events at short and long-term follow-up; Principal
Investigator: Marc Cohen, MD

CRISP AMI Multi-center, randomized, controlled study of mechanical left ventricular unloading with counterpulsation to reduce infarct size pre- PCI for acute myocardial infarction; Principal Investigator: Marc Cohen, MD

CTOT-05 Observational study of alloimmunity in cardiac transplant from the time of transplant to one-year posttransplant; Principal Investigator: David Baran, MD

DURAHEART LVAS Evaluation of the safety and effectiveness the Duraheart Left Ventricular Assist System in patients awaiting heart transplantation; Principal Investigator: Margarita Camacho, MD

HEARTMATE II LVAS Evaluation of the HeartMate II Left Ventricular Assist System as destination therapy versus the HeartMate XVE System; Principal Investigator: Margarita Camacho, MD

IMAGE Invasive Monitoring Attenuation Through Gene Expression Trial; Principal Investigator: David Baran, MD

MARVEL Phase II/III, double-blind, randomized, controlled, multi-center study to assess the safety and cardiovascular effects of MYOCELL implantation by a catheter delivery system in congestive heart failure patients post myocardial infarction(s); trial is temporarily on hold waiting for a protocol amendment from the FDA; Principal Investigator: Mark J. Zucker, MD, JD

Upcoming Trials

CVBT Human recombinant fibroblast growth factor-1 (FGF-1141) for the treatment of subjects with severe coronary heart disease, a double-blind, placebocontrolled, dose- varying study; Principal
Investigator: Mark J. Zucker, MD, JD

REG1-CLIN211 Randomized, partiallyblinded, multi-center, active-controlled, dose-ranging study assessing the safety, efficacy and pharmacodynamics of REG1 Anticoagulation System compared to
unfractionated Harpain or low molecular Heparin in subjects with acute coronary syndrome; Principal Investigator: Marc Cohen, MD

To learn more about the clinical trials conducted at NBIMC please call the cardiac research team at 973.926.8541.

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