GE Healthcare Announces the First in a Series of Major Multi-Center, Multi-Patient Trials to Validate Clinical Efficacy of LightSpeed VCT As a Coronary Artery Disease (CAD) Diagnostic Tool
More than 20 Sites Embark on a Study Comparing GE’s LightSpeed VCT Cardiac Imaging Application to Diagnostic Catheterization, the Current Gold Standard in CAD Assessment
GE Healthcare, a recognized leader in cutting-edge cardiovascular imaging technology, announced today at the American College of Cardiology (ACC) annual scientific sessions in Atlanta, GA., 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. This multi – center trial involving the company’s breakthrough LightSpeed VCT system demonstrates GE’s efforts to re-imagine cardiovascular disease detection by providing non-invasive, lower – cost diagnostic capabilities to combat the number one killer of American men and women.
Cardiac 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 have 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-center, 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 prevention.
“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. “The LightSpeed VCT sets a new technological standard in cardiac image quality and enables cardiologists to non-invasively visualize the human heart more clearly than ever before. We are excited to partner with industry-leading cardiologists in the design and implementation of the first in a series of these very significant multi-center clinical trials.”
Unlike previous clinical studies comparing multi-slice CT with diagnostic cardiac catheterization, GE Healthcare’s multi-center 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-center 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. Budoff.
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-center 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 – center trial is now beginning. GE and its clinical trial partners expect to publish results in 2007.
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GE Healthcare’s broad range of products and services enable healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases, and other conditions earlier. Our vision for the future is to enable a new “early health” model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention. Headquartered in the United Kingdom, GE Healthcare is a $15 billion unit of General Electric Company (NYSE:GE). Worldwide, GE Healthcare employs more than 43,000 people committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our website at www.gehealthcare.com.