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.

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 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 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.

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. 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-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.

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