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

San Donato Group (GSD)

Status: Completed

Conditions: Carotid Artery Plaque; Diagnosis

Treatments: Procedure: Carotid endarterectomy

Study type: Observational

Funder types: Other

Identifiers

NCT05566080

GR-2018-12366862

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.