VULNERABLE PLAQUE DIAGNOSTIC HEAT DETECTOR

The objective of this proposal is to develop an intravascular thermal detector to identify vulnerable coronary artery plaque, which causes acute coronary artery diseases such as: unstable angina, acute myocardial infarction, and sudden cardiac death. The detector will work by sensing small temperature changes between inflamed vulnerable plaque and the neighboring healthy blood vessel wall. This guideware/catheter system for blood vessel surveying will provide a means for diagnosing and then treating vulnerable plaque, which are too small to be detected by angiography, before the plaque rupture and cause the current 70% of heart attacks that are now attributed to them. Coronary angiography is unable to define the status of the atheroma, and only measures the luminal dimensions of the blood vessel, without providing information about plaque content. We have developed a prototype thermal sensor for detecting the small temperature changes associated with vulnerable plaque. In the first phase of this program we will test the efficacy of various sensor designs using an ex vivo blood vessel model in order to converge on a preferred design and test in vivo the safety of the preferred design. In Phase II a complete prototype Thermal Profiling System will be fabricated and evaluated using animal models. PROPOSED COMMERCIAL APPLICATIONS: The commercial and medical value of a device that can enable preemptive treatment of coronary artery disease is self evident. Over 2 million catheterization diagnostic procedures are performed annually worldwide that would immediately quality for augmentation with catheter based diagnosis of vulnerable plaque.