CAS-PRO: Progression Assessment of Carotid Artery Stenosis by Ultrafast Ultrasound Flow Imaging

Sponsor

Rijnstate Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05270005

Collaborator

Radboud University Medical Center (Other)

Enrollment

Locations

Anticipated Duration (Months)

42.5

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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. 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.

Condition or Disease	Intervention/Treatment	Phase
Carotid Artery Stenosis	Diagnostic Test: Ultrasound-based flow imaging Diagnostic Test: Ultrasound-based strain imaging Diagnostic Test: Conventional duplex

Study Design

Study Type:

Observational

Anticipated Enrollment :

85 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Progression Assessment of Carotid Artery Stenosis by Ultrafast Ultrasound Flow Imaging

Anticipated Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Feb 1, 2025

Anticipated Study Completion Date :

Apr 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Asymptomatic carotid artery stenosis Patients with an asymptomatic carotid artery stenosis, defined by 30% to 69% narrowing of the carotid artery according to conventional duplex measurements in the absence of ipsilateral retinal or cerebral ischemia in the preceding 6 months.	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.

Arm

Intervention/Treatment

Asymptomatic carotid artery stenosis

Patients with an asymptomatic carotid artery stenosis, defined by 30% to 69% narrowing of the carotid artery according to conventional duplex measurements in the absence of ipsilateral retinal or cerebral ischemia in the preceding 6 months.

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.

Outcome Measures

Primary Outcome Measures

Two-dimensional spatio-temporal blood flow velocities [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) [2 year follow-up]
Plaque progression, defined by increase in stenosis degree. Stenosis degree will be quantified by conventional ultrasound imaging.

Secondary Outcome Measures

Wall shear stress [2 year follow-up]
Multiple blood flow-related parameters will be derived from the spatio-temporal blood flow velocity data. One parameter is the wall shear stress.
Vorticity [2 year follow-up]
Multiple blood flow-related parameters will be derived from the spatio-temporal blood flow velocity data. One parameter is vorticity.
Vector complexity [2 year follow-up]
Multiple blood flow-related parameters will be derived from the spatio-temporal blood flow velocity data. One parameter is vector complexity.
Plaque progression (deformation) [2 year follow-up]
Plaque progression, defined by change in plaque deformation. Plaque deformation will be quantified by strain imaging.
Symptomatic carotid stenosis [2 year follow-up]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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