Progression Assessment of Carotid Artery Stenosis by Ultrafast Ultrasound Flow Imaging - Trial NCT05270005

Timeline & Enrollment

Primary Outcome

Two-dimensional spatio-temporal blood flow velocities,Plaque progression (stenosis degree)

Summary

Rationale: Approximately 15-20% of strokes originates from an atherosclerotic plaque rupture
 in the carotid artery. To reduce the risk of stroke, patients should be evaluated for
 possible carotid endarterectomy (CEA), which is based on simple geometrical and clinical
 measures. Current guidelines recommend CEA in symptomatic (6months) patients who have 70-99%
 carotid stenosis and CEA should be considered in symptomatic (6months) patients and who have
 50-69% stenosis. Multiple studies have shown that the current risk stratification may lead to
 both over- and under-treatment for patients with carotid artery stenosis. This implicates
 that the current guidelines are lacking patient-specific parameters and have limited
 sensitivity. There is a wealth of evidence implicating the important role of local
 (disturbed) blood flow throughout the onset and progression of atherosclerosis. Novel
 flow-related measures, that go beyond simple geometrical indications, are required to improve
 diagnosis and treatment in patients with carotid artery stenosis. Nowadays, ultrasound (US)
 is one of the main techniques to assess for the presence and extent of carotid artery
 stenosis. However, current clinically-used US systems are unable to acquire and visualize the
 complex flow phenomena that play such a crucial role in the atherosclerotic disease process.
 With the advent of ultrafast ultrasound imaging, acquiring thousands of images per second,
 continuous tracking of flow in all directions became feasible, which enables us to image
 two-dimensional blood flow and possible disturbances with high accuracy and precision.
 
 In this project, we aim to assess whether flow (related) parameters are associated with
 disease progression (and if so, which), in order to map the progression of atherosclerotic
 plaques using non-invasive, US-based blood flow imaging. In the future, this could improve
 risk stratification for individual patients for surgery, decrease patient mortality and
 morbidity, and therefore reduce healthcare costs.
 
 Objective: To longitudinally assess the association between spatio-temporal blood flow
 velocities (peak systole and end-diastole at common carotid artery, maximum stenosis and
 internal carotid artery) and the progression of carotid atherosclerosis defined by duplex
 measurements.
 
 Secondary objectives are to investigate the association between blood flow-derived
 parameters, including wall shear stress (WSS), vector complexity and vorticity, and the
 progression of atherosclerosis defined by duplex measurements. Furthermore, to assess the
 association between spatio-temporal blood flow velocities and blood flow-derived parameters
 (WSS, vector complexity and vorticity) and the progression of atherosclerosis as measured
 using ultrasound-based strain imaging.

ICD-10 Classifications