Trials of GE's 64-slice CT as diagnostic tool for cardiovascular disease
14 March 2005
GE Healthcare announced this week at the American College of Cardiology
(ACC) annual scientific sessions in Atlanta, USA, the company's sponsorship
of the first in a series of multi-center, multi - patient trials to further
validate the clinical efficacy of 64 - slice computed tomography (CT) as a
method for the diagnosis and treatment planning of cardiovascular disease.
The trials at over 20 sites using the company's breakthrough LightSpeed VCT
system are intended to demonstrate the system's non-invasive, lower-cost
diagnostic capabilities in combating cardiovascular disease.
catheterization, the current gold standard for diagnosing CAD, is an
invasive and costly procedure that can impose unnecessary stress to
patients. Data from many sources has indicated that as many one-third of the
patients who undergo an invasive diagnostic catheterization procedure do not
present with significant coronary artery disease and can often be managed
with therapeutics and lifestyle alterations, rather than with the placement
of interventional devices such as stents. The intent of these multi-centre,
multi-patient trials is to determine what role VCT can play in minimizing
non-interventional catheterization as well as how VCT can be used to improve
the early diagnosis of otherwise occult coronary artery disease.
Physicians currently using CT as a diagnostic tool for coronary artery
disease detection are finding that many costly diagnostic catheterization
procedures could be circumvented by utilizing advanced CT systems, such as
GE's LightSpeed VCT for patients presenting with intermediate cardiac risks.
The non - invasive clinical application enabled by the VCT is just one
example of GE's commitment to an "early health" model of patient care,
focused on earlier diagnosis, pre-symptomatic disease detection and disease
"GE is dedicated to developing innovative technologies that improve the
entire patient experience, from early and more accurate diagnosis to better
treatment and management of cardiovascular diseases," said Bill Clarke,
M.D., chief medical and technology officer, GE Healthcare.
Unlike previous clinical studies comparing multi-slice CT with diagnostic
cardiac catheterization, GE Healthcare's multi-centre trial will not only
seek to clinically validate the use of CT for non-invasive diagnosis of CAD,
but will also examine patient results and analyze changes in the
cardiologist's decision-making process and patient management. The latter
are important indicators for determining whether utilizing the LightSpeed
VCT improves patient outcomes and treatment protocols.
Dr. Matthew Budoff, M.D., FACC, Associate Professor of Medicine, Harbor -
UCLA, and the chair of the ACC CT working group, has written ACC-approved
guidelines for appropriate utilization and patient selection for diagnostic
CT procedures. An early adopter of cardiac CT technology, Dr. Budoff is also
a member of the advisory panel that assisted GE in designing protocols for
this major multi-centre clinical trial.
"Cardiovascular disease is responsible for more than 2,600 deaths per day
in the United States. It is extremely important to validate the efficacy of
new cardiac imaging technologies such as multi-slice CT so that the
industry, and in particular medical associations like the American College
of Cardiology, will have the necessary data to recommend appropriate changes
in CAD diagnosis and potentially in cardiac patient management," said Dr.
According to Dr. James Min, M.D., Assistant Professor of Medicine,
Division of Cardiology at Weill Cornell Medical College & New York
Presbyterian Hospitals, and one of the investigators in GE's cardiac CT
multi-centre clinical trial, "CT angiography is the most significant
innovation in cardiology within the last 15 years and offers tremendous
promise for increasing patient safety as a non-invasive diagnostic
procedure, while at the same time identifying disease at an earlier stage
when more treatment options are available."
"Based on my initial findings using the VCT, I strongly believe that
cardiac CT angiography has the potential to dramatically change the way we
practice clinical cardiology, at least in part by significantly reducing the
number of patients who need to undergo an unnecessary invasive diagnostic
catheterization procedure," said Dr. Min.
Dr. David Kandzari, John B Simpson Assistant Professor of Cardiology and
Genomics at Duke University is also a key member of the advisory panel to GE
for the design of this trial. According to Dr Kandzari, "Cardiac CT is
changing clinical practice. We hope that this study will provide solid
clinical evidence to change practice guidelines on the appropriate use of
cardiac CT in patient management."
Patient enrollment in this multi-centre trial is now beginning. GE and
its clinical trial partners expect to publish results in 2007.