Clinical trial NCT05566080: Preoperative Identification of the Histologically "Vulnerable" Plaque Using Non-invasive Imaging, Biomechanical Assessment and Baroreflex Evaluation in Patients With Severe Carotid Stenosis
Official title: Preoperative Identification of the Histologically "Vulnerable" Plaque Using Non-invasive Imaging, Biomechanical Assessment and Baroreflex Evaluation in Patients With Severe Carotid Stenosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carotid Artery Plaque
Diagnosis
Keywords: carotid stenosis
ultrasonic imaging
finite element analysis
Lead sponsor: IRCCS Policlinico S. Donato
Sponsor class: OTHER
Collaborators: name: University of Pavia
name: Ministry of Health, Italy
First posted: 2022-10-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing CEA for a 70-99% asymptomatic stenosis according to ECST measurement of the internal carotid artery at Unit of Vascular Surgery, IRCCS Policlinico San 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Plaque vulnerability
timeFrame: Through study completion, an average of 3 years
measure: Plaque vulnerability
timeFrame: Through study completion, an average of 3 years
measure: Plaque vulnerability
timeFrame: Through study completion, an average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
state: Milan
Study officials:
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