The Saint Barnabas Heart Centers participate in more clinical
research trials than any other cardiac program in New Jersey.
Our prominent cardiovascular research helps patients gain
access to promising new treatments and technology.
The cardiovascular research team participates in industry
sponsored and investigator initiated research projects in
a variety of subspecialties including diagnostic, invasive
and non-invasive cardiology; electrophysiology; heart failure
management; as well as cardiothoracic surgery and cardiac
transplant.
In 2008, our cardiac research team participated in 20 studies
and enrolled more than 100 patients. The team works closely
to incorporate research findings into the comprehensive care
to improve patient outcomes.
For more information about research trials at the
Saint Barnabas Heart Centers, please contact the Cardiac
Research Team at 973-926-8451.
Enrollment
is taking place at a select group of six to eight centers.
The Corcap device is implanted through a thoracotomy incision
in patients with evidence of left ventricular dilatation,
reduced left ventricular function and symptoms of NYHA
class II-IV heart failure despite standard medical therapy.
Patients cannot have mitral regurgitation greater than
2+.
Margarita Camacho, MD
A mesh-like support device designed to reduce left ventricular
dilatation is implanted at the time of mitral valve repair
or replacement.
Margarita Camacho, MD
Neseritide/placebo
administered in addition to standard medical care to evaluate if it
improves patient outcomes. (reduction in composite HF rehospitalization and
all-cause mortality as well as relieving dyspnea symptoms and improving the
subject’s self-assessed overall well-being)
David Baran, MD
Jose Iglesias, MD
An international trial for patients presenting for primary
PCI (percutaneous coronary intervention) of ST elevation
myocardial infarction within 12 hours of symptom onset and
ongoing ischemia will be randomized to treatment with either
IV Enoxaparin or IV unfractionated Heparin. Currently Newark
Beth Israel Medical Center is the only U.S. site participating
in this trial.
Marc Cohen, MD
Subjects with anterior acute ST elevation MI will be randomized
1:1 to either IAB or no IAB before primary PCI. Primary objective
is to determine whether placing an IAB before mechanical
reperfusion decreases anterior MI size. Infarct size will
be measured by MRI 3 to 5 days post-PCI or at discharge,
whichever comes first.
Marc Cohen, MD
An NIH sponsored study to correlate current noninvasive monitoring
tests (angiogram, echo and IVUS) with long term graft survival/function
in heart transplant recipients and determine which tests
are the most accurate predictors of survival.
David Baran, MD
This is a multi-center, prospective, single arm study. The
patient population for this trial consists of patients with
end-stage heart failure awaiting cardiac transplantation.
Patients must be listed for transplant with UNOS as status
1A or 1B.
Margarita Camacho, MD
Implantation of the HM II LVAS in patients as destination
therapy for treatment of end stage heart failure. These patients
are not transplant candidates and receive the device for
long-term cardiac support. **Device now marketed for
bridge to transplant.
Margarita Camacho, MD
A randomized trial designed to evaluate the safety and efficacy
of gene expression profiling (GEP) in the monitoring of asymptomatic
heart transplant patients for acute rejection. The primary
objective is to determine whether the use of GEP is not inferior
to biopsy with respect to event-free survival.
David
Baran, MD
Patients
undergoing PCI with lesions able to be treated with 2.25
to 3.5 mm Cypher stent.
Phase 1-
Non-randomized open label thienopyridine with aspirin therapy for 12 months.
Phase 1- Randomized: patients who are treated with 12 months
of DAPT are randomized to 18 months of DAPT or placebo. Both
arms will continue aspirin therapy. The primary endpoint
is target lesion failure or MACE events.
Marc Cohen, MD
This is a phase II, multi-center study using three dose levels
of FGF-1141 and a placebo dose in subjects who demonstrate
evidence of advanced symptoms of coronary heart disease despite
optimization of conventional medical therapy, and CCS classification
scores of Class II and IV.
The dose will be given as 10 myocardial injections (via the
NOGA MyoStar injection catheter) into those areas of the
left ventricle shown to be perfusion-limited by SPECT analyses,
with supporting confirmation of localized ischemia by an
angiogram.
Mark J. Zucker, MD, JD
Implantation of autologous skeletal myoblasts post-myocardial
infarction with the use of the NOGA XP cardiac navigation
system. The myoblasts have the potential to differentiate
into mature muscle and may lead to improvement of myocardial
performance. **trial is temporarily on hold waiting for a
protocol amendment with the FDA
Mark J. Zucker, MD, JD
Novel first in class anticoagulation system consisting of
a drug component (RB006, an oligonucleotide aptamer) and
the active control agent specific to RB006 (RB007). Randomized
to 1 of 5 parallel treatment groups. Groups 1 through 4 will
receive a bolus of 1.0 mg/kg of RB006 and differing degrees
of control-reversal agent RB007. Group 5 will receive Heparin.
All subjects will have loading doses of both Clopidogrel
and Aspirin.
Marc Cohen, MD
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