Newswatch: May 2006

GE Healthcare announces first of 20 multi-center trials, new research agreement

GE Healthcare (Waukesha, Wis) is now sponsoring the first in a series of multi-center, multi-patient trials to test the clinical efficacy of 64-slice CT as a method for the diagnosis and treatment planning of cardiovascular disease. Additionally, the company has announced it has signed a 6-year research agreement with St Joseph's Hospital and Medical Center (Phoenix) to establish an alliance in medical research.

First, the multi-center trials involve the company's LightSpeed VCT system for cardiovascular-disease detection. The intent of these trials is to determine what role VCT can play in minimizing noninterventional catheterization, as well as how VCT can be used to improve the early diagnosis of otherwise occult coronary artery disease. The trials also attempt to clinically validate the use of CT for noninvasive diagnosis of coronary artery disease as well as to examine patient results and analyze changes in the cardiologist's decision-making process and patient management. The latter indicators are important for determining whether using the LightSpeed VCT improves patient outcomes and treatment protocols.

James Min, MD, is an assistant professor of medicine in the division of cardiology at Weill Cornell Medical College and New York Presbyterian Hospitals and one of the investigators in the cardiac CT multi-center clinical trial. "CT angiography is the most significant innovation in cardiology within the past 15 years," Min said, "and it offers tremendous promise for increasing patient safety as a noninvasive diagnostic procedure while also identifying disease at an earlier stage when more treatment options are available.

"Based on my initial findings using the VCT," Min continued, "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."

For the trial, patients who are prescribed a catheterization as a part of their diagnostic regimen will additionally receive a VCT exam, and the results of both exams will be compared. In addition to measuring the effectiveness of the LightSpeed VCT as a diagnostic tool with the cath, this trial will evaluate the decision-making process of the cardiologist and how it is affected by the use of the VCT. According to GE Healthcare, the company hopes to show that with the use of the VCT, cardiologists were able to make clinically confident decisions in a less-invasive manner for better patient outcomes.

Patient enrollment in this multi-center trial is now beginning, and more than 500 patients are expected to be enrolled. According to the company, this will be the largest patient population ever studied for assessment of cardiac CT. GE Healthcare and its clinical trial partners expect to publish results in 2007.

Next, GE Healthcare's 6-year research agreement with St Joseph's is expected to advance personalized healthcare by accelerating joint research efforts and quickly transitioning those discoveries into the clinical environment.

According to leaders at both organizations, this research alliance will focus on a number of technologies, including the continuation of new MR applications. For example, James Pipe, PhD, a bioengineer at the Barrow Neurological Institute at St Joseph's, developed a new method that allows technologists to obtain clearer MR scans with less sensitivity to patient motion. This breakthrough technology, called PROPELLER (periodically rotated overlapping parallel lines with enhanced reconstruction), has been incorporated into all of GE Healthcare's Signa HD MR scanners. PROPELLER provides increased image clarity in cases involving patients who are difficult to scan due to movement disorders (including children who have traditionally required sedation to undergo scans and Parkinson's disease patients).