CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
Carotid endarterectomyprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05566080
NCT05566080N/ACompleted

Preoperative Identification of the Histologically "Vulnerable" Plaque Using Non-invasive Imaging, Biomechanical Assessment and Baroreflex Evaluation in Patients With Severe Carotid Stenosis

IRCCS Policlinico S. Donato·observational·Posted Oct 4, 2022·Updated Dec 28, 2023

In Brief

An observational study evaluating Carotid endarterectomy for Carotid Artery Plaque and Diagnosis. Completed, enrolled 100 participants across 1 site.

Detailed Summary

Carotid artery stenosis due to atherosclerotic plaques accounts for an important cause of ischemic stroke. Current research seeks to risk stratify asymptomatic patients by characterizing rupture-prone plaques. Currently no single imaging modality can reliably identify those plaques before surgery. Recently, the 3D ultrasound (US) and the assessment of the mechanical stress on the vessel wall have been proposed as non-invasive tools that could play a role in the diagnostic work-up. Data of histological validation, however, are still needed. In this research, 3D US, non-invasive elastography, Finite Element Analysis of computed tomography angiography images and the study of the autonomic cardiovascular control will be used to identify preoperatively the vulnerable plaque in patients undergoing carotid endarterectomy. The results will be compared to that of histology of the removed plaque, aiming to provide a validation to each method for a possible application in the daily practice.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesItaly

Timeline

N/ACompletedFinished
20222023202420252026
First PostedOct 4, 2022
Enrollment StartMar 15, 2021
Primary CompletionSep 30, 2023
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 3.7 years ago

Interventions

Carotid endarterectomyprocedure

Patients who have a significant carotid stenosis and who undergo surgical carotid endarterectomy