The ASI Non-Invasive Arterial Stiffness Screening Device (ASI Device) is an investigational
device under development for the non-invasive assessment of arterial stiffness. The ASI
Device is considerably smaller and more cost effective than its commercially available
counterparts. As the device is readily portable, it is intended to be targeted for use in the
community (or at home), as opposed to within the hospital or clinic setting only. However, as
the device is still under development, it is not known whether it is capable of determining
arterial stiffness with the same sensitivity and consistency as those already in commercial
use. An added variable is the fact the sensor for the ASI Device is located on the fingertip.
Validation is a prerequisite for obtaining Health Canada approval of devices for diagnostic
purposes. The ASI Device has not been tested against other instruments capable of providing
similar measurements. Therefore, a clinical trial to compare the ASI Device against similar
devices is necessary. The study will compare measurements of arterial stiffness and other
central haemodynamic parameters obtained with the ASI Device against similar measurements
from devices that have already been approved for this purpose by Health Canada/United States
Food and Drug Administration (FDA).