Research

Clinical Research

In October of 2005, InfraReDx successfully completed a Feasibility Study with the Near Infrared (NIR) Spectroscopy System in 10 patients undergoing percutaneous coronary intervention (PCI).

In 2006 InfraReDx initiated the SPECTACL Study (Spectroscopic Assessment of Coronary Lipid) in 5 centers in the US and Canada. Spectral maps have been obtained in over 30 patients. The intent of this study is to gather spectral signals, which can be compared with spectral signals obtained in a parallel autopsy-based study in human coronary arteries in which histologic analysis is available to serve as a gold-standard for detection of lipid-rich plaques.

For additional information about the SPECTACL Study see: www.clinicaltrial.gov

InfraReDx seeks to conduct additional clinical studies in partnership with pharmaceutical and medical device companies. A Registry is being designed with the goal of helping to better understand the linkage between NIR signals indicating the presence of a lipid-rich plaque and subsequent coronary events. The Company will also collaborate with investigator-initiated studies related to its corporate goals.

Ex Vivo

Several investigations documenting that NIR spectroscopy can correctly identify lipid-rich plaques in autopsy specimens have been completed by InfraReDx and other investigators. The InfraReDx studies include a study conducted in human aortas with a commercial spectrometer (Moreno et al, 2002), and a study in human coronary arteries with a probe-based system in which measurements were taken through various depths of blood. (Marshick et al).

InfraReDx is currently conducting a study in intact human coronary artery autopsy specimens that are perfused with blood (the CDEV3 study). After the NIR measurements are obtained, the specimens are analyzed by histologic techniques to identify lipid-rich plaques. An algorithm to identify lipid-rich plaque on the basis of the NIR spectra is being constructed on a calibration set, and will be evaluated in a blinded fashion as a validation set.

Limited by federal (US) law to investigational use.