Predicting unstable carotid plaques using radiomics and biomechanics
Official title: Predicting High-Risk Carotid Plaque: Integrating radioMics and biomEchanics
Run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · NCT07877480 · Data updated 2026-11-12
This study tests a noninvasive model to identify unstable carotid plaques in adults at initial diagnosis who may be candidates for carotid surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 420 (estimated) |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Milan) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | September 30, 2026 |
| Study ends | December 30, 2026 |
| Registry record updated | October 16, 2026 |
| Trial ID | NCT07877480 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with significant carotid atherosclerosis (stenosis ≥70% ECST), eligible for carotid endarterectomy, and with available preoperative imaging.
✕Probably not a fit
Patients without significant plaques, those not indicated for surgery, or lacking preoperative imaging may not benefit from this predictive model.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will integrate radiomic features from imaging with biomechanical data to predict plaque instability in patients with significant carotid atherosclerosis. The study uses prospective–retrospective data and biological samples to develop a predictive model. The goal is to identify high-risk plaques in asymptomatic patients before any stroke occurs, complementing existing risk stratification methods. Eligible participants are adults with stenosis of 70% or more who are planned for carotid endarterectomy and have preoperative imaging. This work could guide earlier, targeted interventions and reduce stroke risk.
Why it matters
Potential benefit: If successful, the model could help doctors identify patients at higher risk of stroke so they can plan timely preventive treatment.
How similar studies have gone: Radiomics and biomechanical analyses have shown promise in characterizing plaque features, though integrating both for prediction in asymptomatic patients is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients ≥ 18 years of age; * Affected by significant carotid atherosclerosis, whether symptomatic or asymptomatic (stenosis ≥ 70% according to ECST criteria). * Candidates for carotid ATE surgery. The criteria provided by the SICVE and ESVS guidelines will be followed for indications for surgery; * Preoperative imaging available; Exclusion Criteria: * Patients who have undergone previous carotid endarterectomy (ipsilateral to the affected side); * Patients who have undergone previous neck surgery involving cervical lymph node dissection; * Patients who have undergone previous neck radiation therapy; * Lack of preoperative imaging; * Patients unable to sign informed consent.
Where it's running
-
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.