NCT05566080

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: IRCCS Policlinico S. Donato · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Carotid Artery Plaque
• Diagnosis

Interventions

Type	Name	Description
PROCEDURE	Carotid endarterectomy	Patients who have a significant carotid stenosis and who undergo surgical carotid endarterectomy

Timeline

• Start date: 2021-03-15
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2022-10-04
• Last updated: 2023-12-28

Locations

1 site across 1 country: Italy