Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05270005
Study type Observational
Source Rijnstate Hospital
Contact
Status Recruiting
Phase
Start date April 7, 2022
Completion date April 1, 2025

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03931161 - Effect of Evolocumab on Carotid Plaque Composition in Asymptomatic Carotid Artery Stenosis (EVOCAR-1) Phase 4
Recruiting NCT03353103 - Imaging of Unstable Carotid Plaque in Patient Referred to Endarterectomy Phase 2
Completed NCT03996148 - Time to Post-Anesthesia Neurological Evaluation With Three Different Anesthetic Techniques Phase 4
Recruiting NCT05968053 - Detection of Microplastics and Nanoplastics in Neurosurgery Patients (DT-MiNi)
Completed NCT00318851 - Carotid Artery Stenting With Protection Registry Phase 3
Completed NCT00597974 - Neurological Outcome With Carotid Artery Stenting N/A
Active, not recruiting NCT05293067 - Troponin In Carotid Revascularization
Completed NCT03133429 - Clinical Study to Evaluate the Safety and Effectiveness of MER® Stents in Carotid Revascularisation. N/A
Recruiting NCT01440036 - The Correlation Between the Enzyme Paraoxigenase 1 (PON1) to Carotid Artery Atheromatous Plaque N/A
Completed NCT00417963 - ViVEXX Carotid Revascularization Trial (VIVA) Phase 3
Completed NCT00177346 - A Randomized Trial of Carotid Artery Stenting With and Without Cerebral Protection N/A
Recruiting NCT05574972 - Timing Carotid Stent Clinical Study for the Treatment of Carotid Artery Stenosis(Timing Trial) N/A
Recruiting NCT02476396 - Structural Stability of Carotid Plaque and Symptomatology
Completed NCT05451485 - VFI in Healthy Vessels
Recruiting NCT06033963 - Safety and Efficacy of Remote Ischemic Conditioning in Patients With Carotid Artery Stenosis Receiving Carotid EndArterectomy N/A
Not yet recruiting NCT02224209 - Comparison of Staged Angioplasty and Routine Single-stage Stenting (CAS) in the Treatment of Carotid Artery Stenosis Phase 4
Completed NCT02006095 - Neuroimaging Correlates of Memory Decline Following Carotid Interventions
Terminated NCT01236508 - Relation of Carotid Artery Plaque Inflammation, Covert Stroke and White Matter Disease Phase 4
Recruiting NCT05126238 - A Lithium-Based Medication to Improve Neurological Outcomes After Surgical Carotid Reconstruction Phase 3
Recruiting NCT06170580 - Improved Image Quality for Assessment of Carotid Artery Stenosis by Ultrafast Ultrasound FLOW Imaging