Actively Recruiting
Evaluation of Carotid Plaque Stiffness by Shear Wave Elastography, Greyscale Median, MRI, and Histopathology: Diagnostic Accuracy Study
Led by UPECLIN HC FM Botucatu Unesp · Updated on 2025-04-06
43
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the stiffness of carotid atherosclerotic plaques using shear wave elastography (SWE) compared to greyscale median values (GSM), magnetic resonance imaging (MRI), and histopathological findings. The study includes patients with carotid plaques causing stenosis over 50%, whether symptomatic or not, to determine if plaque stiffness is related to other imaging or pathological measures. Participants undergo vascular ultrasound exams where SWE and GSM are measured. MRI is used to confirm stenosis severity. Those with symptomatic stenosis above 50% or asymptomatic stenosis above 70% may be considered for surgical treatments such as endarterectomy or angioplasty. If surgery is performed, plaque tissue is analyzed histopathologically. The study does not influence treatment decisions. During the study, participants have ultrasound and MRI imaging, with some undergoing surgery and tissue examination. Researchers measure plaque stiffness, greyscale values, MRI indicators of plaque instability, and histopathological features if surgery occurs. Additional outcomes include plaque surface, location, fibrotic cap, echolucent areas, echogenicity, ulceration, and blood flow velocities. The study follows participants for an average of two years to collect these diagnostic data.
CONDITIONS
Brief Title
Shear Wave Elastography for Carotid Atherosclerotic Plaques
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with atherosclerotic carotid plaques causing stenosis greater than 50%.
You will not qualify if you...
- Previous surgery on the neck area.
- Prior radiotherapy to the neck.
- Stenosis caused by vascular inflammatory diseases.
- Pregnant women.
- High carotid bifurcation that cannot be reached by ultrasound probe.
- Posterior acoustic shadowing that prevents plaque evaluation by ultrasound.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants undergo diagnostic tests including vascular ultrasound, shear wave elastography, greyscale median assessment, magnetic resonance imaging, and histopathology if surgery is performed.
Visits as needed for imaging and assessments over the study period
Duration - Approximately 2 years
Participants are monitored for plaque characteristics and progression over an average of 2 years.
Follow-up visits scheduled as per protocol for ongoing assessments
Trial Site Locations
Total: 1 location
1
Sao Paulo State University
Botucatu, São Paulo, Brazil, 18618-970
Actively Recruiting
Research Team
P
Pedro L Mellucci Filho, M.D.
M
Marcone L Sobreira, Ph.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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