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Clinical Trials/NCT05270005
NCT05270005
Active, not recruiting
Not Applicable

Progression Assessment of Carotid Artery Stenosis by Ultrafast Ultrasound Flow Imaging

Rijnstate Hospital2 sites in 1 country85 target enrollmentApril 7, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Carotid Artery Stenosis
Sponsor
Rijnstate Hospital
Enrollment
85
Locations
2
Primary Endpoint
Two-dimensional spatio-temporal blood flow velocities
Status
Active, not recruiting
Last Updated
last year

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
April 7, 2022
End Date
December 1, 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Rijnstate Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adult male or female (≥18 years old);
  • Informed consent form understood and signed, and patient agrees to follow-up visits;
  • Presence of carotid artery stenosis (between 30%-69%) according to conventional duplex measurements (peak-systolic velocity of 125-230 cm/s \[5\] in combination with visible lumen reduction \>30% according to North American Symptomatic Carotid Endarterectomy Trial \[NASCET\] method);
  • Defined asymptomatic with respect to the ipsilateral carotid artery stenosis.

Exclusion Criteria

  • A planned carotid revascularisation for the ipsilateral carotid artery stenosis at date of inclusion;
  • History of carotid revascularisation at artery under investigation;
  • Visible near occlusion at asymptomatic stenosis side according to conventional duplex measurements;
  • Life expectancy \< 2 years;
  • Participating in another clinical study, interfering on outcomes

Outcomes

Primary Outcomes

Two-dimensional spatio-temporal blood flow velocities

Time Frame: 2 year follow-up

Two-dimensional vector velocity fields derived from the US-based flow imaging will be used to calculate the spatio-temporal blood flow velocities.

Plaque progression (stenosis degree)

Time Frame: 2 year follow-up

Plaque progression, defined by increase in stenosis degree. Stenosis degree will be quantified by conventional ultrasound imaging.

Secondary Outcomes

  • Wall shear stress(2 year follow-up)
  • Vector complexity(2 year follow-up)
  • Vorticity(2 year follow-up)
  • Plaque progression (deformation)(2 year follow-up)
  • Symptomatic carotid stenosis(2 year follow-up)

Study Sites (2)

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