Carotid Artery Plaque Vulnerability Assessment Using Ultrafast Ultrasound Techniques

NCT05218421 | Unknown

• 1 other identifier: 112669
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

Objective: To explore the association between spatio-temporal blood flow velocities (peak systole and end-diastole at prior-stenosis, at maximum stenosis, and post-stenosis) and carotid plaque vulnerability defined by histology staining. Secondary, to assess the association between ultrasound elastography and carotid plaque vulnerability defined by histology staining. Furthermore, to assess the association between blood flow-derived parameters, including wall shear stress (WSS), vector complexity and vorticity, and plaque vulnerability. To evaluate the hemodynamic consequences of a CEA. Last, to explore whether the presence of circulating biomarkers is related to the degree of plaque vulnerability (as reflected by histology and/or ultrasound). Study design: A multicentre, prospective, observational, cohort study in a total of 70 patients. Study population: Patients with a carotid artery stenosis ≥50% according to clinically performed imaging (i.e. duplex, computed tomography angiography (CTA), or magnetic resonance angiography (MRA)) that are scheduled for a CEA. Intervention (observational): A carotid ultrasound with flow and elastography (strain and shear wave) measurements will be performed maximally 2 weeks prior to the CEA. In the first 20 included patients in the Radboudumc, a 10 mL blood sample will be collected during surgery via the arterial line that is applied for regular care. The plaque excised during CEA will be histologically examined to assess the plaque composition, and therefore plaque vulnerability. Ultrasound-based flow imaging will be repeated six weeks after the CEA to assess the hemodynamic consequences of the CEA procedure. Besides, clinical parameters will be subtracted from electronic health record or, if missing, anamnestically collected from the patient. Main study parameters/endpoints: Association between 2D spatio-temporal blood flow velocities (peak systole and end-diastole at prior-stenosis, maximum stenosis and post-stenosis), measured by ultrafast ultrasound measurements, and plaque vulnerability (stable versus unstable), defined by histology staining.

Conditions

Carotid Artery Plaque

Keywords

Ultrasound; Shear wave elastography; Atherosclerotic plaques; Strain elastography; Ultrafast ultrasound flow imaging; Histological plaque characterization

Outcome Measures

Primary Outcomes (1)

• Assocation between 2D blood flow velocities and plaque vulnerability

  Explore the association between 2D spatio-temporal blood flow velocities (peak systole and end-diastole prior-stenosis, at maximum stenosis and post-stenosis) and atherosclerotic carotid plaque vulnerability (stable versus unstable), defined by histology staining.

  Time Frame: max 2 weeks prior to CEA

Secondary Outcomes (6)

• Association strain and plaque vulnerability

  Time Frame: max 2 weeks prior to CEA

• Association shear wave elastography measures and plaque vulnerability

  Time Frame: max 2 weeks prior to CEA

• Association blood flow-related parameters and plaque vulnerability

  Time Frame: max 2 weeks prior to CEA

• Comparison predictive value for plaque vulnerability ultrafast imaging techniques vs clinically-used measurements

  Time Frame: max 2 weeks prior to CEA

• Status 2D blood flow velocity profiles and flow-related parameters prior- and post-CEA

  Time Frame: max 2 weeks prior to CEA and 6 weeks after CEA

Study Arms (1)

Participants

Patients with a carotid artery stenosis ≥50% according to clinically performed imaging (i.e. duplex, computed tomography angiography (CTA), or magnetic resonance angiography (MRA)) that are scheduled for a CEA.

Diagnostic Test: Carotid ultrasound; Other: Biospecimen collection and examination; Other: Blood sample collection

Interventions

Carotid ultrasound DIAGNOSTIC_TEST

Carotid ultrasound with flow and elastography (strain and shear wave) measurements will be performed maximally 2 weeks prior to the CEA. Ultrasound-based flow imaging will be repeated six weeks after the CEA to assess the hemodynamic consequences of the CEA procedure.

Participants

Biospecimen collection and examination OTHER

The plaque excised during CEA will be histologically examined to assess the plaque composition, and therefore plaque vulnerability.

Participants

Blood sample collection OTHER

In the first 20 included patients in the Radboudumc, a 10 mL blood sample will be collected during surgery via the arterial line that is applied for regular care.

Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with a carotid artery stenosis ≥50% according to clinically performed imaging (i.e. duplex, computed tomography angiography (CTA), or magnetic resonance angiography (MRA)) that are scheduled for a CEA.

You may qualify if:

• Presence of carotid artery stenosis (≥50%) according to conventional clinically performed imaging (duplex/CT(A)/MR(A)) and scheduled for a CEA;
• Possibility to perform carotid ultrasound ≤2 weeks before the CEA
• ≥18 years old;
• Able to provide signed or oral informed consent.

You may not qualify if:

• Hampered carotid blood flow imaging during clinically performed duplex/doppler measurements due to near to total carotid occlusion at the side of interest or a calcified plaque;
• Restenosis after carotid revascularisation at side of interest;
• Participating in another clinical study, interfering on outcomes;

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Rijnstate Hospital: collaborator

Study Sites (2)

Rijnstate Hospital

Arnhem, Netherlands

Location

Radboud university medical center

Nijmegen, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Atherosclerotic plaque carotid artery

MeSH Terms

Conditions

Carotid Stenosis; Plaque, Atherosclerotic

Interventions

Ultrasonography, Carotid Arteries; Restraint, Physical

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 1, 2022
• Study Start: February 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: November 1, 2023
• Last Updated: February 1, 2022

Record last verified: 2022-01

Locations

NL (2)