SonoSite Initiates Multi-Center Cardiovascular Research Study; Ultrasound Study to Assess Carotid Intima Media Thickness in an O
November 13 2005 - 6:19PM
Business Wire
SonoSite, Inc. (Nasdaq:SONO), the world leader in hand-carried
ultrasound, announced today at the 2005 American Heart Association
(AHA) Scientific Sessions that it is initiating a multi-center
study to determine whether the addition of an ultrasound
examination evaluating carotid artery wall thickness (CIMT),
performed in the office setting, will provide a more effective tool
for risk assessment and prevention of cardiovascular disease than
current clinical methods alone. Over 20 years of clinical research
has shown that the thickness (T) of the two innermost layers of the
carotid artery wall, the intima (I) and media (M), begins to
increase before plaque is evident within the vessel. This increased
wall thickness is associated with an increased risk of
cardiovascular disease, the leading cause of mortality and
disability in the United States today. "IMT addresses the need to
identify those patients who are asymptomatic or have limited risk
factors, such as moderately elevated cholesterol levels, who may be
at greater than apparent risk for a cardiovascular event," explains
James H. Stein, MD, Associate Professor, University of Wisconsin
Medical School. Dr. Stein is the Director of the University of
Wisconsin Atherosclerosis Imaging Research Program and principal
investigator of the study. "Although IMT is recognized as a
valuable adjunct in cardiovascular risk stratification, it
primarily has been used as a research tool," Dr. Stein stated.
"With the advent of high-resolution, hand-carried ultrasound
systems and software algorithms, it is more practical to
incorporate this tool into clinical practice. Through this trial,
we hope to determine if health care professionals can accurately
perform this exam in the office setting and thereby detect
cardiovascular disease before it causes a heart attack or stroke."
Until recently, measuring cholesterol or C-Reactive Protein (CRP),
an indicator of blood vessel inflammation, have been among the few
options in evaluating the risk of cardiovascular disease. However,
clinical studies suggest that IMT may be more predictive and
specific to cardiovascular risk than either CRP or traditional
lipid profile alone, making IMT an important tool for identifying
patients at increased risk for cardiovascular disease. Called
"OPACA" for Office Practice Assessment of Carotid Atherosclerosis
using Handheld Ultrasound Study, investigators plan to enroll 525
patients at medical centers located in Philadelphia; Minneapolis;
New York City; Chicago; Boise, Idaho; and Rochester, Minnesota.
Data collection and analysis is expected to be completed by June of
2006. The study will use SonoSite's MicroMaxx(TM) system with
embedded SonoCalc(TM) software, a hand-carried ultrasound system
weighing just under eight pounds, and a L38 linear array
transducer. The noninvasive ultrasound examination can be completed
in approximately 15 minutes and does not expose a patient to
ionizing radiation. "Moving IMT out of the research lab and into
the physician's office is part of our long-term vision for
incorporating ultrasound into the physical examination," said Kevin
M. Goodwin, SonoSite President and CEO. "We are pleased to join
with Dr. Stein and the other study investigators in their efforts
to find practical and cost-effective methods for preventing and
lowering the risk of heart disease." Introduced a year ago at the
2004 AHA Scientific Sessions, SonoSite's patented SonoCalc(TM) IMT
automated edge detection technology provides physicians with the
ability to analyze the IMT of a patient's carotid artery. IMT has
been used as an indicator of efficacy in the development of several
statin and antihypertensive drugs and is widely recognized as a
surrogate marker for identifying and evaluating the vascular
disease and its progression, both indicators of heart disease and
stroke. SonoSite will be offering IMT screenings in Booth 533
during the AHA Scientific Sessions from November 13-16 being held
at the Dallas Convention Center. For more information on the OPACA
trial, contact Hal Widlansky, Global Director, Cardiovascular at
425-951-1206. About SonoSite SonoSite, Inc. (www.sonosite.com) is
the innovator and world leader in hand-carried ultrasound, with an
installed base of more than 20,000 systems. Headquartered near
Seattle, SonoSite is represented by eight subsidiaries and a global
distribution network in over 75 countries. SonoSite's small,
lightweight systems are expanding the use of ultrasound across the
clinical spectrum by cost-effectively bringing high-performance
ultrasound to the point of patient care. The company employs
approximately 470 people worldwide.
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