Carotid Artery Plaque, Diagnosis
Conditions
Keywords
carotid stenosis, ultrasonic imaging, finite element analysis
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.
Interventions
PROCEDURECarotid endarterectomy
Patients who have a significant carotid stenosis and who undergo surgical carotid endarterectomy
Sponsors
University of Pavia
Ministry of Health, Italy
IRCCS Policlinico S. Donato
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plaque vulnerability | Through study completion, an average of 3 years | To assess the correlation between the result of 3D US in identifying preoperatively the features of vulnerable plaque (plaque volume; presence of a lipidic core/intraplaque hemorrhage/plaque ulceration; fibrous cap thickness) and that of the histological analysis, in patients who will undergo CEA for a 70-99% carotid stenosis. To assess the correlation between the US-SE parameters to plaque vulnerability, as defined by the histological analysis. |
Countries
Italy
Outcome results
None listed