NCT05270005: CAS-PRO

Progression Assessment of Carotid Artery Stenosis by Ultrafast Ultrasound Flow Imaging

Active, enrolled Last updated 12 February 2025

What this trial tests

trial testing Ultrasound-based flow imaging in Carotid Artery Stenosis in 85 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

7 April 2022

Primary endpoint
1 September 2026

1 December 2026

Quick facts

Lead sponsor	Rijnstate Hospital
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	85
Start date	7 April 2022
Primary completion	1 September 2026
Estimated completion	1 December 2026
Sites	2 locations across Netherlands

Drugs / interventions tested

• Ultrasound-based flow imaging
• Ultrasound-based strain imaging
• Conventional duplex

Conditions studied

• Carotid Artery Stenosis — all drugs for Carotid Artery Stenosis →

Sponsor

Rijnstate Hospital

Who can join

18 and older, any sex, with Carotid Artery Stenosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.