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

NCT05566080 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2023-12-28

No results posted yet for this study

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

PROCEDURE

Carotid endarterectomy

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

Sponsors & Collaborators

  • University of Pavia

    collaborator OTHER

  • Ministry of Health, Italy

    collaborator OTHER_GOV

  • IRCCS Policlinico S. Donato

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-15
Primary Completion
2023-09-30
Completion
2023-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05566080 on ClinicalTrials.gov