PRINCETON, NJ Bracco Diagnostics Inc. has announced it has partnered with Toshiba Medical Systems Corporation in supporting a landmark clinical trial aimed at assessing the viability of using multislice computed tomography (CT) as a primary diagnostic tool for detecting cardiovascular diseases and disorders, in comparison to cardiac catheterization.

The study, named CorE 64 for coronary evaluation on 64 is the first multi-center clinical study to focus specifically on computed tomography angiography (CTA) using 64-slice CT technology. Patient evaluations are expected to take place for several months, and initial study results are planned for release in 2006.

Braccos contrast agent Isovue-370, the highest concentration iodine agent approved for CT imaging in the United States, will be provided for non-invasive diagnostic imaging of cardiac patients in conjunction with Toshiba CT technologies, including the AquilionTM CFX 64-slice CT scanner, the 64-row Quantum Detector, as well as SURECardioTM and SUREPlaqueTM applications.

According to Bracco Diagnostics Inc. President and Chief Executive Officer Carlo Medici, the study will be a highly important benchmark in assessing one of the fastest growing CT applications in the diagnostic imaging arena.

Bracco firmly believes that this is a necessary endeavor, and that cardiologists and radiologists need a large-scale, controlled study to accurately gauge the viability of Coronary CTA, clarify much of the prevailing hype, and perhaps instill greater confidence in this diagnostic imaging application, said Medici. We are proud to work with Toshiba Medical Systems Corporation in this regard, because Bracco places a priority focus on supporting clinical research that addresses specific market issues and helps move the process of innovation in diagnostic imaging forward.

According to Bracco, Isovue-370 was selected for the trial because it is the only product in the US market that is approved at this iodine concentration (370mgI/ml) for CT. The use of high iodine nonionic agents in conjunction with multislice CT equipment is already widely accepted amongst the imaging community. High concentration agents can provide the necessary iodine delivery rate (IDR) safely and still match the power and speed of 64-slice CT scanners.

In the study, CTA will be used to visualize soft plaque, measure coronary stenosis, plan quantitative treatment, and calculate plaque burden.

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