Validation of an Open-Source Tool for Measuring Carotid Lumen Diameter and Intima-Media Thickness.

In low- and middle-income regions, a relatively large number of deaths occur from cardiovascular disease or stroke. Carotid intima-media thickness (cIMT) and carotid lumen diameter (cLD) are strong indicators of cardiovascular event risk and stenosis severity, respectively. The interactive open-source software described here, Cimtool, is based on active contours for measuring these indicators in clinical practice and thus helping in preventive diagnosis and treatment. Cimtool was validated using carotid phantoms and real images obtained using ultrasound. Expert users measured cIMT and cLD in regular practice and also with Cimtool. The results obtained with Cimtool were then compared with the results for the manual approach in terms of measurement agreement, time spent on the measurements and usability. Intra-observer variability when using Cimtool was also analyzed. Statistical analysis revealed strong agreement between the manual method and Cimtool (p > 0.01 for cIMT and cLD). The correlation coefficient for both cIMT and cLD measurements was r > 0.9. Moreover, this software allowed the users to spend considerably less time on each measurement (3.5 min per study versus 50 s with Cimtool on average). An open-source, interactive, validated tool for measuring cIMT and cLD clinically was thus developed. Compared with the manual approach, Cimtool's straightforward measurement flow allows the user to spend less time per measurement and has less standard deviation. The coefficients of variation for measurements and intra-observer variability were lower than those reported for recent automated approaches, even with low-quality images.