Clinical trial NCT05218421: Carotid Artery Plaque Vulnerability Assessment Using Ultrafast Ultrasound Techniques
Official title: Carotid Artery Plaque Vulnerability Assessment Using Ultrafast Ultrasound Techniques
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carotid Artery Plaque
Keywords: Ultrasound
Shear wave elastography
Atherosclerotic plaques
Strain elastography
Ultrafast ultrasound flow imaging
Histological plaque characterization
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Rijnstate Hospital
First posted: 2022-02-01
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;

Primary outcomes:
measure: Assocation between 2D blood flow velocities and plaque vulnerability
timeFrame: Time Frame: max 2 weeks prior to CEA
Secondary outcomes:
measure: Association strain and plaque vulnerability
timeFrame: Time Frame: max 2 weeks prior to CEA
measure: Association shear wave elastography measures and plaque vulnerability
timeFrame: Time Frame: max 2 weeks prior to CEA
measure: Association blood flow-related parameters and plaque vulnerability
timeFrame: Time Frame: max 2 weeks prior to CEA
measure: Comparison predictive value for plaque vulnerability ultrafast imaging techniques vs clinically-used measurements
timeFrame: Time Frame: max 2 weeks prior to CEA
measure: Status 2D blood flow velocity profiles and flow-related parameters prior- and post-CEA
timeFrame: Time Frame: max 2 weeks prior to CEA and 6 weeks after CEA
measure: Association circulating inflammatory cytokines and plaque vulnerability
timeFrame: Time Frame: During CEA
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
city: Nijmegen
country: Netherlands
facility: Radboud university medical center
Study officials:
References: