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

Completed

• Conditions: Carotid Artery Plaque; Diagnosis

• Registration Number: NCT05566080
• Lead Sponsor: IRCCS Policlinico S. Donato

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-15
• Study First Submitted: 2022-09-28
• Study First Submitted QC: 2022-09-30
• Study First Posted: 2022-10-04
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-27
• Last Update Posted: 2023-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• age above 18 years;
• signed informed consent.

Exclusion Criteria

• medical conditions limiting expected survival to <1 year;
• patients with significant uncontrolled or unstable medical condition (heart failure or angina pectoris class NYHA III-IV, cardiac surgery in the previous 30 days, left ventricular ejection fraction <30%, severe chronic obstructive pulmonary disease, myocardial infarction in the previous 30 days, coronary heart disease with revascularization indication, that is, the common trunk or more than two coronary vessels);
• tracheostomy;
• paralysis of the laryngeal nerve contralateral to the carotid stenosis;
• women of childbearing potential;
• inability to give informed consent;
• patients presenting contraindications to perform a CTA examination of neck vessels with contrast medium;
• patients with medical history of stroke/TIA within the previous 6 months.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plaque vulnerability	Through study completion, an average of 3 years	To develop software routines to process US B-mode and US-SE images; to determine the mechanical stress patterns on the vessel wall by the different types of carotid plaques through the FEA of preoperative CTA scans of the recruited patients, and their correlation with the plaque histology and 3D US images. relation with the histological analysis of the carotid plaque after CEA.

Trial Locations

Locations (1)

IRCCS Policlinico San Donato; 🇮🇹 San Donato Milanese, Milan, Italy