NCT05270005

Progression Assessment of Carotid Artery Stenosis by Ultrafast Ultrasound Flow Imaging

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 85 (estimated)
• Sponsor: Rijnstate Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Carotid Artery Stenosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Ultrasound-based flow imaging	Ultrasound-based flow imaging of the carotid artery stenosis will be acquired at baseline and two annual follow-up appointments.
DIAGNOSTIC_TEST	Ultrasound-based strain imaging	Ultrasound-based strain imaging of the carotid artery stenosis will be acquired at baseline and two annual follow-up appointments.
DIAGNOSTIC_TEST	Conventional duplex	Conventional duplex measurements of the carotid artery stenosis will be acquired at baseline and two annual follow-up appointments.

Timeline

• Start date: 2022-04-07
• Primary completion: 2026-09-01
• Completion: 2026-12-01
• First posted: 2022-03-08
• Last updated: 2025-02-12

Locations

2 sites across 1 country: Netherlands