Toshiba Clinical Trials Advance CT and Ultrasound
Cardiovascular disease claimed 831,272 lives in the United States in 2006, accounting for one of every 2.9 deaths, according to the American Heart Association. In three different clinical trials, Toshiba America Medical Systems is validating the use of CT and ultrasound technology for noninvasive, earlier detection of the signs of heart disease.
The three trials include: CorE 64, the largest trial ever initiated evaluating the use of 64-detector row CT, which investigated the use of multidetector-row CT as the primary diagnostic tool for detecting cardiovascular diseases and disorders; faCTor64, which evaluates the use of CT angiography (CTA) and echocardiography as diagnostic tools; and CORE 320, which examines whether the combination of CTA and myocardial perfusion can identify coronary stenoses of 50 percent or less (by quantitative coronary analysis) that correspond to SPECT perfusion defects.
In all three cases, validating the technology for noninvasive, early diagnosis of cardiovascular disease or defects could change how cutting-edge technology improves outcomes. Rich Mather, senior manager, Clinical Programs at Toshiba Medical Research Institute USA, says, “We expect CORE 320 findings to affect the way the medical community views the role of dynamic volume CT in the diagnosis and treatment of life-threatening diseases. When these results are available they could eventually have an impact on the way patients are diagnosed and treated.”
The CORE 320 study, which recently commenced at Johns Hopkins University School of Medicine, compares the effectiveness of 320-detector row CT angiography and perfusion with that of the combination of SPECT and coronary catheterization in identifying coronary stenoses with an associated perfusion defect. Johns Hopkins will serve as the core site for CT, while Brigham and Women’s Hospital in Boston will be the core site for SPECT. Mather explains that the multisite approach is designed to provide statistically reliable data. He says, “The trial’s design calls for an international, multicenter approach, bypassing the limitations of study bias and those associated with focusing on one geographic area and/or small patient populations.”
Toshiba’s faCTor64 study looks at the use of both 64-detector row CT and echocardiography in diagnosing coronary heart disease (CHD). Around 300,000 U.S. residents per year experience their first symptoms of CHD as either heart attack or sudden death, but there is no accepted detection test for the presence of the disease. On the CT side, the study, performed in conjunction with Intermountain Healthcare in Salt Lake City, will look at 1,000 patients over the age of 50, using Toshiba’s Aquilion® 64-detector row CT system to capture both obstructive and nonobstructive CHD data to determine the best method of treatment.
The faCTor64 research picks up where Toshiba’s CorE 64 study left off; the CorE 64 results,1 which were published in the November 27, 2008, issue of the New England Journal of Medicine, investigated CT’s ability to detect disease, as compared with that of diagnostic catheterization. The faCTor64 work not only focuses on detection of the disease in asymptomatic patients, but also assesses whether the ability to detect and treat coronary-artery disease has improved patient outcomes. “We believe the results of faCTor64 will improve the diagnosis and treatment of diabetic patients, who are more likely to develop CHD,” Mather explains. “This study will provide optimal information to guide patient management and measure clinical outcomes.”
In a recently announced faCTor64 substudy known as Speckle Tracking by Echo, Intermountain Healthcare will also examine the use of Toshiba’s Wall Motion Tracking (WMT) ultrasound technology to evaluate asymptomatic patients with diabetes for CHD. Using echocardiography to evaluate patients could help physicians detect disease noninvasively at its earliest stages, bypassing more costly procedures like catheterization.
WMT evaluates one region of the heart muscle to show how it is moving in relation to other regions, revealing even subtle abnormalities; 300 patients have already been enrolled in the substudy. J. Brent Muhlestein, MD, director of cardiovascular research at Intermountain Healthcare and the study’s lead investigator, says, “So far, Wall Motion Tracking shows significant promise as an inexpensive, noninvasive tool to detect subtle differences in how regions of the heart muscle are working.”
All three studies are aimed at providing additional information to direct patient management and track clinical outcomes. Donald L. Lappe, MD, chief of cardiology at Intermountain Healthcare, says, “Patients with diabetes have a two-to-four times greater risk of cardiovascular disease than nondiabetic patients. The ability to detect CHD in at-risk, asymptomatic patients will have a significant impact on the ability to improve their cardiac conditions and will help save lives.”
Reference
1. Miller JM, Rochitte CE, Dewey M, et al. Diagnostic performance of coronary angiography by 64-row CT. N Engl Med. 2008;359(22):2324-2336.
Reference
1. Miller JM, Rochitte CE, Dewey M, et al. Diagnostic performance of coronary angiography by 64-row CT. N Engl Med. 2008;359(22):2324-2336.
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Tags: Clinical Trials, CT, Ultrasound
Category: Education & Training —