| CLINICAL
RESEARCH
The clinical research
activity of the Department of Thoracic and Cardiovascular Surgery consists
of approximately 70 individuals devoted to generation of new knowledge
in the treatment of thoracic and cardiovascular diseases. The activity
is divided somewhat arbitrarily into those related to observational clinical
studies (including translational research from basic science to clinical
relevance) and those related to clinical trials. At any given time, approximately
200 projects are in various stages of activity.
Clinical
studies (CS) utilize retrospective and prospective data that
is specially gathered on groups of patients undergoing treatment. Short-
and long-range patient outcomes are related to patient, disease, and treatment
factors. These studies utilize data registries, such as the Cardiovascular
Information Registry (CVIR), that contain patient and follow-up data on
over 200,000 patients
Clinical
trials (CT), in contrast, are studies of specific patient groups
enrolled in trials of new treatment modalities, such as devices and medicines.
Many are multi-site, industry-sponsored trials. The trials are often randomized
to make the most reliable comparisons.
The research group
is a multidisciplinary one that combines expertise and clinical knowledge,
information and data analysis technology, data gathering, and the surgical
experience of the investigators that include staff, clinical fellows,
full-time research fellows, residents, and nurses. The full-time research
fellows may elect to participate in a two-year didactic program leading
to a Master’s degree. Each resident is involved in a project that
leads to a presentation on Residents’ Day.
The individuals in
these clinical research activities are directed by Dr. Eugene Blackstone.
In late 1997, he was recruited from an endowed professorial position at
the University of Alabama at Birmingham to lead the cardiovascular surgery
clinical research program. He is also a full staff member of the Department
of Biostatistics and Epidemiology. His long association as a full-time
professional investigator with Dr. John Kirklin has equipped him for this
leadership role. He was one of the founders of the field of digital signal
processing, is considered a leader in the molecular biology of cardiopulmonary
bypass and biocompatibility, and has developed biomathematical models
of time-related risks that are used for multivariable modeling of time-related
data.
METHODOLOGIC RESEARCH
In addition to data
gathering, analyses pertaining to specific topics, reporting activities,
manuscript and presentation preparation, methodologic research is also
prominent. This includes further development of Hazard
Function Technology embodied as a powerful software package. This
package was developed originally by Dr. Blackstone’s group at the
University of Alabama at Birmingham and now being maintained and expanded
at The Cleveland Clinic Foundation. It is useful for assessment of risk
factors for time-related events.
Current
Cardiovascular Surgery Research
The Cleveland Clinic
Foundation (CCF) is a not-for-profit, multi-specialty academic medical
center that integrates clinical and hospital care with research and education.
The founders of the Cleveland Clinic believed research and education were
the cornerstones of excellence in patient care. The Cleveland Clinic Foundation
puts patients first through improved outcomes, better services and providing
a healthier future for all.
Based on these guiding
principles, you may be approached for participation in research studies
during your visit to CCF. Participation in any research is completely
voluntary. Your desire not to participate will not affect your care or
treatment in any way.
If a patient/family
has a desire to be involved in a particular research study, they should
tell their physician about the interest. The physician will be able to
direct the patient and family to a study that is suitable for their particular
condition.
Below are summaries
of ongoing research projects. There are other projects that are not listed
due to having stringent criteria for admission to the research study.
Ischemic
Heart Disease
(CT
= Clinical Trials; CS = Clinical Studies)
Ischemic
heart disease is caused by blockage of the blood vessels that supply nutrients
to the heart muscle. Identification of these blockages and operations
to bypass them were pioneered at The Cleveland Clinic Foundation. Additionally,
operations may be needed to correct damage to the heart muscle that occurs
after heart attacks.
CS: Coronary Artery
Bypass Grafting in Patients Having a Variety of Other Important Diseases
(Comorbidities)
We are studying the
long-term fate of patients who have had coronary bypass grafting with
accompanying diabetes, radiation therapy and neurologic complications,
and mild aortic valve disease. We are also studying effects of cardiopulmonary
bypass, atrial fibrillation, and outcomes of tracheostomy.
Physicians: Delos
Cosgrove MD, Michael K. Banbury MD, A. Marc Gillinov MD, Bruce W. Lytle
MD, Joseph Sabik MD, Nicholas G. Smedira MD
CS: Surgical Coronary
Venous Bypass Grafting (Pilot Study)
This study will evaluate
the safety and feasibility of Coronary Venous Bypass Grafting as an alternative
to medical management for patients with an ischemic region of myocardium
that is not amenable to conventional revascularization methods. Patients
eligible for this study are those that have viable myocardium in the area
of the RCA that can not be grafted.
Physician: A.
Marc Gillinov MD is Primary Investigator, the rest of cardiothoracic surgery
staff are co-investigators.
CS: Ischemic Mitral
Regurgitation
Following some heart
attacks, the one-way valve between the left ventricle (main pumping chamber)
and its receiving chamber (the left atrium), called the mitral valve,
becomes leaky (regurgitation). This may be caused by disruption of the
apparatus that normally tethers the valve. It may come from dysfunction
of the heart muscle or dilation of the heart. Currently, it is not known
which of these valves should be repaired and which should be replaced.
In the largest study of its kind to-date, we are ascertaining the durability
of repair, possible survival advantage in some patients of valve repair
vs. replacement, and the mechanism of regurgitation on the basis of three-dimensional
echocardiography.
Physician: A.
Marc Gillinov MD
CS: Minimally Invasive
Coronary Artery Surgery
We are investigating
the possible benefits of less invasive operations for treatment of coronary
artery disease. This includes studying the possible beneficial effects
of off-pump bypass, differing approaches for reoperation, and other minimally
invasive approaches.
Physicians: Joseph
Sabik MD, A. Marc Gillinov MD, Gosta B. Pettersson MD, Jose L. Navia MD
CS: Ventricular Pseudoaneurysm
We are studying the
outcomes over time of pseudoaneurysm in the left ventricle (small or large
area of scarred muscle that becomes thin and out-pouches [like a balloon]
with each heartbeat).
Physician: Jose
L. Navia MD
CS: Post Infarction
Ventricular Septal Defect
A particularly devastating
complication of a heart attack is a hole developing between the pumping
chambers (postinfarction ventricular septal defect). Over the last 20
years, there has been considerable improvement in results of surgery for
postinfarction ventricular septal defect. This difficult and life-threatening
condition requires urgent surgery. Analysis of our extensive experience
with patients experiencing this event guides current operative strategy.
Physicians: A.
Marc Gillinov MD
CS: Radial artery
Bypass Grafts
Radial artery grafts
are being used for conduits in place of leg veins. These arteries are
not as protected from developing their own disease, as is the internal
thoracic artery, pioneered by The Cleveland Clinic Foundation. The long-term
fate of these grafts is being studied.
Physician: Gosta
B. Pettersson MD
Surgery
for Heart Failure
(CT
= Clinical Trials; CS = Clinical Studies)
For various reasons, sometimes well understood, such as after
one or multiple heart attacks, and sometimes not well understood, the
heart muscle weakens. Usually the heart dilates, very similar to blowing
up a balloon. Heart transplantation can be lifesaving, but the availability
of suitable donors is limited. Therefore, in this category of heart failure,
we are investigating not only various aspects of heart transplantation,
but also alternatives to heart transplantation, including left ventricular
assist devices and surgical options.
CS: Cleveland
Clinic Experience in Coronary Artery Bypass Graft plus/minus Mitral Valve
Repair and plus/minus Left Ventricular Reconstruction Surgery
A retrospective investigation
of outcomes of patients after heart attack (myocardial infarction) with
systolic heart failure having the above procedures (alone or in combination)
to determine if there is a difference in survival and the need for future
reoperation or cardiac transplantation among the groups. We hope to learn
the optimum method of treating patients with heart failure after myocardial
infarction.
Physicians: Nicholas
G. Smedira MD, Michael Banbury MD, Jose Navia, MD
CT: Clinical
Investigation of the DeBakey LVAD with Comparison to Performance Goal
to Establish Safety and Effectiveness of the Device as Left Ventricular
Support in Patients Awaiting Cardiac Transplantation
This study will
determine the effectiveness and safety of the DeBakey VAD ® in providing
circulatory support, as a bridge to transplant, in patients who are awaiting
heart transplant. The
device, an axial flow pump, provides ventricular assistance using a small,
lightweight, and mechanically simple design.
Primary Investigator:
Nicholas Smedira, M.D.
Co-Investigator(s): Jose Navia, M.D., Michael Banbury, M.D.
Contact Person: Roseanne
Schott, RN (216) 445-9484
CT: The Evaluation
of the HeartMate II LVAS For Use as a Bridge To Transplant and for Destination
Therapy in Patients Not Eligible for Heart Transplant
The purpose of this
multicenter feasibility study is to evaluate the preliminary safety and
potential effectiveness of the HeartMate II LVAS device in patients with
end-stage heart failure in patients not eligible for heart transplant.
Primary Investigator:
Nicholas Smedira, M.D.
Co-Investigator(s): Jose Navia, M.D., Michael Banbury, M.D.
Contact Person: Roseanne Schott, RN (216) 445-9484
CT: Randomized
Clinical Trial of the Safety and Efficacy of the DeBakey VAD® as a
Destination Therapy in Patients with End-Stage Heart Failure
Cardiac transplantation
is the established treatment for patients with end-stage heart failure.
Many patients are not candidates for cardiac transplantation. The other
alternative to transplantation in this population is mechanical circulatory
support. A clinical trial is underway to evaluate the safety and efficacy
of the DeBakey VAD® device in providing long-term circulatory support
for patients who have NYHA Class IV heart failure and who are not eligible
for transplant. Participants will randomly receive either a Debakey VAD®
or a HeartMate® XVE LVAD (TC).
Primary Investigator:
Nicholas Smedira, M.D.
Co-Investigator(s): Jose Navia, M.D., Michael Banbury, M.D.
Contact Person: Roseanne Schott, RN (216) 445-9484
CT: A Pivotal,
Randomized, Controlled Study to Evaluate the Safety and Effectiveness
of the Novacor ® Left Ventricular Assist System ( LVAS) for Patients
Who Are Not Eligible for Cardiac Transplantation
This study is designed
to evaluate the Novacor LVAS to determine safety and effectiveness in
patients who are not eligible for cardiac transplantation. Participants
must be NYHA Class IV, have end-stage LVF, have received optimal medical
therapy for at least 60 of last 90 days, have a life expectance of less
that two years, and not eligible for cardiac transplant.
Primary Investigator:
Nicholas Smedira, M.D.
Co-Investigator(s) s): Jose Navia, M.D., Michael Banbury, M.D.
Contact Person: Roseanne Schott, RN (216) 445-9484
CT: phVEGF
165 Gene Transfer to Promote Angiogenesis in Patients with
Advanced Heart Failure
Patients who have
advanced congestive heart failure (CHF) secondary to idiopathic dilated
cardiomyopathy may be eligible for enrollment in a single-center, phase
I, double-blind, placebo-controlled, dose escalating study of Intra-Myocardial
phVEGF165 Gene transfer. The study will be conducted on 2 groups
of participants, those with ischemic and those with non-ischemic heart
failure.
Primary Investigator
Investigator: Nicholas Smedira, M.D.
Co-Investigators Investigators: Jose Navia, M.D., Michael Banbury, M.D.
Contact Person: Roseanne
Schott, RN (216) 445-9484
CT: A Prospective
, Multi-Center, Randomized, Placebo-Controlled Trial to Assess the Effects
of Nitric Oxide for Inhalation during LVAD Implantation
This trial will attempt
to safely demonstrate if patients undergoing LVAD placement may benefit
from treatment with nitric oxide.
Primary Investigator:
John Pierre Yared M.D.
Co-Investigator: Nicholas Smedira, M.D.
Contact Person: Roseanne
Schott, RN (216) 445-9484
CT: Minimally
invasive approaches to lead placement for cardiac resynchronization therapy
(CRT) with biventricular pacing
CRT leads are usually
placed in the heart by an electrophysiologist during a procedure that
involves conscious sedation. However, some patients cannot have their
left ventricular lead placed in this usual manner due to coronary anatomy
or other conditions. The left ventricular lead can be surgically placed
in the proper position epicardially (on the outer surface of the heart).
This is performed during a routine heart surgery procedure or it can also
be performed using small keyhole thoracotomy incisions or through robot-assisted
surgery. We are investigating the various approaches to placing the left
lateral CRT lead and reviewing clinical outcomes associated with this
methodology.
Primary Investigator
Investigator(s): Nicholas Smedira, M.D., Jose Navia, M.D.
Contact Person: Roseanne
Schott, RN (216) 445-9484
CT: Surgical
Treatment for Ischemic Heart Failure (STICH)
This is a multi-center,
international study for patients with coronary artery disease and heart
failure. Patients are randomized within three arms of the study based
on their condition.
Primary Investigator(s):
Nicholas Smedira, M.D., Randall Starling, M.D.
Co-investigators:
Tomislav Mihaljevic, M.D., Jose Navia, M.D., Michael Banbury, M.D., Joseph
Sabik, M.D., Bruce Lytle, M.D.
Contact Person: Roseanne Schott, RN (216) 445-9484
For
more information on heart failure research:go
to:
Arrhythmia
Surgery
(CT
= Clinical Trials; CS = Clinical Studies)
The heart has its
own system of specialized cells that generate the heartbeat conducted
to all parts of the heart. Sometimes, for either well-known reasons or
less well understood reasons, the heartbeat (rhythm) becomes abnormal.
Most disturbances of heart rhythm are managed by various types of artificial
pacemakers or devices that can supply electrical energy to the heart to
keep it beating. Occasionally, surgery is needed to eliminate the abnormal
rhythm.
CS: Maze Procedure
for Atrial Fibrillation
Long-term follow-up
of the Maze operation for patients with chronic atrial fibrillation or
symptomatic paroxysmal atrial fibrillation has recently been completed.
Studies indicate over 90% of patients have been returned to sinus rhythm
and there have been no embolic events (blood clots let loose) in follow-up
with the clinical experience approaching 200 patients. Ongoing studies
are investigating late clinical events.
Physician: A.
Marc Gillinov, MD
CT: Surgical Treatment
of Atrial Fibrillation
Surgery to eliminate
atrial fibrillation has been augmented by the development of new ablation
methods. In addition to the conventional method of surgical incisions
(maze procedure) , microwaves, radiofrequency waves and cryo-ablation
are now available. All of these methods are currently used for specific
patient populations. The AtriCure Bipolar Coagulation System has 510K
approval from the FDA for soft tissue coagulation. This system coagulates
the soft tissue and provides feedback on the electrical property and temperature
of the tissues being ablated. A clinical trial is currently evaluating
efficacy and safety:
Physicians: A.
Marc Gillinov, MD
Contact Person: Roseanne
Schott, RN (216) 445-9484
Click
here to learn more about atrial fibrillation research
Valve
Surgery
(CT
= Clinical Trials; CS = Clinical Studies)
The heart contains
four one-way valves that make blood flow move in one direction ("forward")
when the heart beats. These valves can become leaky, or infected, or partially
closed by various disease processes. Ideally, the valve can be repaired.
If not, it must be replaced. We are interested in knowing the durability
of repair and whether or not it is possible, what device is best in the
long-term if it cannot be repaired, and what the consequences are in the
long-term of valve repair and replacement.
CS: Tricuspid Valve
Repair
Traditionally the
tricuspid valve has been replaced rather than repaired. The durability
of tricuspid valve repair, using an annulopasty system, is being tested.
Physicians: Joseph
Sabik, MD and A. Marc Gillinov, MD
CS: Simultaneous
Aortic and Mitral Valve Disease
Recent data from
our institution reveals that patients with combined aortic and mitral
valve disease are best served by aortic valve replacement and mitral valve
repair rather than double valve replacement. Continued analysis of these
patients will help to guide clinical decision making in patients with
combined aortic and mitral valve disease.
Physician: A. Marc
Gillinov, MD
CS: Mitral
Valve Repair for Rheumatic Heart Disease
There is controversy
as to the appropriate treatment for patients with rheumatic mitral valve
disease with some surgeons advocating repair rather than replacement.
Current studies seek to identify the relative merits of mitral valve repair
versus replacement in this patient group.
Physician: A. Marc
Gillinov, MD
CS: Aortic
Valve Devices
Several studies of
various replacement devices for the aortic valve (the valve that separates
the left ventricle from the aorta) are being conducted to determine not
only their long-term outcome, but also to match the right valve to the
right patient.
Physicians: Eugene
H. Blackstone MD, Delos M. Cosgrove MD
CS: Ross
procedure (pulmonary autograft aortic valve and root replacement) follow-up
A follow-up study
of the Ross operation performed by a single surgeon at the CCF has been
performed. Clinical follow up revealed occurrence of early autograft valve
regurgitation and stenosis of the pulmonary allograft. An echocardiographic
follow-up is being performed to study pre-, peri- and postoperative factors
associated with failure as well as the mode of failure. The Ross operation
is presently offered to selected patient with aortic valve disease below
the age of 40-50 years. The selection criteria for the Ross operation
as well as the surgical technique have been modified. These patients have
been entered into a prospective follow up study of clinical outcome and
autograft and allograft function.
Physicians: Delos
Cosgrove MD, Gosta Pettersson MD, Eugene Blackstone MD
CS:
Aortic Allograft Study
Cryopreserved human
aortic valves (homografts or allografts) provide optimal hemodynamics
while avoiding the need for anticoagulation. The valve's durability needs
to be defined. To accomplish this, the 5-10 year freedom from valve-related
complications and valve failure in over 500 patients is being evaluated.
Physicians: Delos
Cosgrove MD, Gosta Pettersson MD
CT: New Aortic
Bioprosthetic Valve
To increase the options
available for patients who require aortic valve replacement, a multicenter
trial is being conducted to evaluate the safety and efficacy of a new
Aortic Stentless Equine Pericardial Bioprosthesic valve.
Physicians: Gosta
Pettersson, MD, Michael Banbury, MD, Jose Navia, MD, Nicholas Smedira,
MD
Contact Person: Roseanne Schott, RN (216) 445-9484
Thoracic
Aorta
(CT
= Clinical Trials; CS = Clinical Studies)
The aorta is the main
artery that conducts blood from the left ventricle (main pumping chamber)
to the body. It may become enlarged and this is called an aneurysm. Its
layers may become separated and this is called a dissection.
CS: Ascending Aortic
Aneurysms and Dissections
We are studying the
long-term fate of patients whose ascending aortic aneurysms or dissections
have been repaired. More so than at other centers, each operation is tailored
to the specific pathology of the aorta, resulting in a number of variations
of the repair. These variations are being studied as to their long-term
durability and effectiveness.
Physician: Joseph
Sabik MD
CT: Brain
Protection During Aortic Arch Replacement
In patients who undergo aneurysm surgery with the use of cardiopulmonary
bypass (CPB), retrograde cerebral perfusion is used to protect the brain
from stroke. CPB is temporarily suspended during the most critical part
of the operation and blood is perfused backward through the brain. A randomized
study is being conducted to determine which method of brain perfusion
retrograde or antegrade is better at protecting the brain against injury
after aortic arch replacement
Physicians: Lars Svensson
MD and Bruce Lytle, MD
Contact Person: Roseanne Schott, RN (216) 445-9484
COMPLICATIONS
OF HEART SURGERY
(CT
= Clinical Trials; CS = Clinical Studies)
No treatment of heart
disease is without complications. Thus, a goal of cardiac surgeons at
The Cleveland Clinic Foundation is to reduce these complications to a
minimum.
CT: A Study
Comparing Angiomax® (bivalirudin) to Heparin with Protamine Reversal
in Patients Undergoing On-Pump Coronary Artery Bypass
The purpose of this
study is to demonstrate that Angiomax is a safe and effective alternative
to heparin in patients undergoing cardiac surgery on coronary artery bypass.
Physicians: Nicholas
Smedira, MD
Contact Person: Roseanne Schott, RN (216) 445-9484
For a list of recently
published articles by our staff:
Copies of publications
can be obtained from the National
Library of Medicine PubMed or ask your local librarian for assistance.
9/07 revised |
