Assessing carotid plaque stiffness using ultrasound techniques
Evaluation of Atherosclerotic Carotid Plaque Stiffness by Shear Wave Elastography, Greyscale Median, Magnetic Resonance Imaging and Histopathological Analysis: Diagnostic Test Study
UPECLIN HC FM Botucatu Unesp · NCT06214429
This study is testing a new ultrasound method to see if it can accurately measure how stiff plaque in the carotid arteries is, which might help doctors understand more about the condition and decide on treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 43 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UPECLIN HC FM Botucatu Unesp (other) |
| Locations | 1 site (Botucatu, São Paulo) |
| Trial ID | NCT06214429 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the accuracy of shear wave elastography (SWE) in measuring the stiffness of carotid atherosclerotic plaques and compare it with greyscale median values, MRI findings, and histopathological results. Participants will undergo vascular ultrasound to assess plaque stiffness and confirm stenosis through MRI. Those with significant stenosis may be considered for surgical intervention, and the removed plaques will be analyzed histopathologically. The study seeks to determine if plaque stiffness correlates with other imaging and pathological findings.
Who should consider this trial
Good fit: Ideal candidates are patients with carotid atherosclerotic plaques causing stenosis greater than 50%.
Not a fit: Patients with previous cervical surgery, radiotherapy, or those with stenosis due to inflammatory diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the diagnostic accuracy for assessing carotid atherosclerosis and guide treatment decisions.
How similar studies have performed: Similar studies using elastography techniques have shown promise in assessing plaque characteristics, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with atherosclerotic carotid plaques that develop stenosis superior to 50%. Exclusion Criteria: * Previous cervical surgery; * Previous cervical radiotherapy; * Stenosis caused by vascular inflammatory diseases; * Pregnant women; * High carotid bifurcation (inaccessible by vascular ultrasound linear probe); * Posterior acoustic shadowing that impair morphological evaluation of the plaque.
Where this trial is running
Botucatu, São Paulo
- Sao Paulo State University — Botucatu, São Paulo, Brazil (RECRUITING)
Study contacts
- Study coordinator: Pedro L Mellucci Filho, M.D.
- Email: p.mellucci@unesp.br
- Phone: +5518997378864
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Carotid Atherosclerosis