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NCT Number: NCT05270005

Progression Assessment of Carotid Artery Stenosis by Ultrafast Ultrasound Flow Imaging

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound-based flow imaging

Diagnostic Test

Ultrasound-based flow imaging of the carotid artery stenosis will be acquired at baseline and two annual follow-up appointments.

Ultrasound-based strain imaging

Diagnostic Test

Ultrasound-based strain imaging of the carotid artery stenosis will be acquired at baseline and two annual follow-up appointments.

Conventional duplex

Diagnostic Test

Conventional duplex measurements of the carotid artery stenosis will be acquired at baseline and two annual follow-up appointments.

Primary outcomes

  1. 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.

  2. 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

  1. Wall shear stress

    Time frame: 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.

  2. Vorticity

    Time frame: 2 year follow-up

    Multiple blood flow-related parameters will be derived from the spatio-temporal blood flow velocity data. One parameter is vorticity.

  3. Vector complexity

    Time frame: 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.

  4. Plaque progression (deformation)

    Time frame: 2 year follow-up

    Plaque progression, defined by change in plaque deformation. Plaque deformation will be quantified by strain imaging.

  5. Symptomatic carotid stenosis

    Time frame: 2 year follow-up

Sponsors and collaborators

Lead sponsor

Rijnstate Hospital

Other

Collaborators

  • Radboud University Medical Center

Registry information

Acronym: CAS-PRO

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 8, 2022
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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