A phase II clinical trial found that the CardioPET imaging agent correctly identified ischemia in exercise and pharmacologic stress studies in patients with coronary artery disease. The diagnostic accuracy of CardioPET was similar to that of single-photon emission computed tomography (SPECT) imaging.
The results were presented at the American Society of Nuclear Cardiology annual meeting on Sept. 24 in Boca Raton, Florida. FluoroPharma Medical, which manufactures CardioPET, announced the results in a news release.
CardioPET, an F-18 labeled, modified fatty acid used in cardiac PET imaging, is not yet FDA-approved. FluoroPharma Medical is evaluating the use of CardioPET to identify patients who will benefit from PCI or revascularization, assess myocardial variability and evaluate coronary artery disease in patients who cannot exercise.
The study enrolled 24 patients who had abnormal findings for clinically indicated SPECT scans with technetium-labeled compounds, which are the standard test for non-invasive diagnosis of coronary artery disease.
Patients were given a single dose of CardioPET with a comparable exercise or pharmacologic stress test or when they were at rest. The researchers compared the SPECT and PET images to coronary angiography to assess diagnostic performance.
“In this study, the unique fatty acid signal for CardioPET was shown to detect both ischemia and myocardial infarction,” Gary Heller, MD, of Morristown Medical Center in New Jersey and one of the trial’s researchers, said in a news release. “We were particularly intrigued with abnormal CardioPET images in subjects who were injected at rest, yet still had evidence of CAD on angiography. This indicates that it may be feasible to find CAD without an exercise test, and certainly should be studied further.”