Web-based accurate measurements of carotid lumen diameter and stenosis severity: An ultrasound-based clinical tool for stroke risk assessment during multicenter clinical trials

Abstract

Background: This pilot study presents a completely automated, novel, smart, cloud-based, point-of-care system for (a) carotid lumen diameter (LD); (b) stenosis severity index (SSI) and (c) total lumen area (TLA) measurement using B-mode ultrasound. The proposed system was (i) validated against manual reading taken by the Neurologist and (ii) benchmarked against the commercially available system.

Method: One hundred patients (73 M/27 F, mean age: 68 ± 11 years), institutional review board approved, written informed consent, consisted of left/right common carotid artery (200 ultrasound scans) were acquired using a 7.5-MHz linear transducer.

Results: The measured mean LD for left and right carotids were (in mm): (i) for proposed system (6.49 ± 1.77, 6.66 ± 1.70); and (ii) for manual (6.29 ± 1.79, 6.45 ± 1.63), respectively and coefficient of correlation between cloud-based automated against manual were 0.98 (P < 0.0001) and 0.99 (P < 0.0001), respectively. The corresponding TLA error, Precision-of-Merit, and Figure-of-Merit when measured against the manual were: 4.56 ± 3.54%, 96.18 ± 3.21%, and 96.85%, respectively. The AUC for the receiving operating characteristics for the cloud-based system was: 1.0. Four statistical tests such as: Two-tailed z-test, Mann-Whitney test, Kolmogorov-Smirnov (KS) and one-way ANOVA were performed to demonstrate consistency and reliability.

Conclusions: The proposed system is reliable, accurate, fast, completely automated, anytime-anywhere solution for multi-center clinical trials and routine vascular screening.

Keywords: Carotid arteries; Cloud-based; Lumen diameter; Stenosis; Stroke; Total lumen area; Ultrasound.