Skin Sterol Test in Trial

A new point-of-care (POC) test soon to be in a clinical trial does not require fasting or drawing of blood but tests for the amount of sterol in the skin, also known as skin tissue cholesterol, as an indicator of coronary artery disease.

Called the Prevu(x) POC, the system has been developed in two test formats. The Prevu(x) Skin Sterol Test LT, a lab-processed test, samples skin cells from the palm of the hand, using a patent-pending device with medical-grade adhesive. The device is then sent to a lab where the surface is assessed for skin sterol. The second version is a single-use, three-minute home test, called Prevu(x) PT. Both were developed by International Medical Innovations, Inc. (IMI, Toronto, Canada; www.imimedical.com).

The multicenter trial, which will involve 600 patients scheduled for coronary angiography and 100 healthy age- and gender-matched controls, will be performed at multiple sites in Canada, including the Montreal Heart Institute. Patients will be tested on both systems. A fasting serum sample will also be taken and tested for traditional risk factors.

"Prevu(x) POC is noninvasive and delivers results quickly, which makes it a potentially effective tool to help identify patients who are at higher risk of coronary artery disease--the number one cause of heart attack,” noted Dr. Jean-Claude Tardif, director of Clinical Research at the Montreal Heart Institute and associate professor of medicine at the University of Montreal. "Prevu(x) LT is even simpler to administer, and, if proven successful, will make skin sterol testing even more widely available.” Dr. Tardif is the principal investigator in the study.




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