New Haven, Conn. -- Yale will be the lead test site for a $3.2 million national study aimed at earlier diagnosis of the leading silent killer of persons with diabetes -- heart disease.
The study was designed by Frans J. Th. Wackers, M.D., a professor of medicine at the Yale School of Medicine and is funded at Yale and six other test sites by DuPont Pharmaceuticals Co. and Fujisawa Healthcare Inc. Enrollment of patients begins today.
"There are nearly 16 million people with diabetes in the United States and coronary heart disease has been diagnosed in about 20 percent of them," said Wackers. "However, it is known that within one year, another 12 percent of asymptomatic persons with diabetes will either die, suffer a heart attack, or will be diagnosed with advanced coronary heart disease. At the present time we cannot predict who these persons are. Obviously, it is not feasible to screen millions of persons with diabetes."
The goal of the study, titled "Detection of Ischemia in Asymptomatic Diabetics (DIAD)," is earlier diagnosis of heart disease in these patients.
The study will include a total of 1,000 subjects at seven test sites throughout the U.S. The patients must be exhibiting no clinical signs of heart disease. All of the subjects in the study first will undergo a physical examination for possible unrecognized heart problems. Half of the subjects in the randomized study will undergo a stress test along with myocardial perfusion imaging. The patients then will be examined every six months over the three-year period of the study.
DuPont markets Cardiolite, which is a radioactive dye agent used to assess the blood flow through the heart. In this study, the dye is used to monitor heart muscle blood flow while a patient is undergoing a stress test with Adenoscan, marketed by Fujisawa. Adenoscan increases heart muscle blood flow. The heart's ability to increase heart muscle blood flow can be imaged and gives an indication about the presence of coronary heart disease.
"We want to see how often we can detect coronary heart disease that is not yet clinically evident," Wackers said. "We then will determine a 'risk profile' of the diabetic patient with high probability of silent coronary heart disease. This will provide important and widely applicable guidelines for which asymptomatic persons with diabetes should be screened for silent heart disease and who should not."