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

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.

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Key information

Conditions

Carotid Artery Plaque Arterial Occlusive Diseases Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Carotid Stenosis Central Nervous System Diseases Cerebrovascular Disorders Diagnosis Disease Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Policlinico San Donato

San Donato Milanese, Milan, 20097, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

carotid endarterectomy

Procedure

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

Primary outcomes

Plaque vulnerability

Time frame: 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.
Plaque vulnerability

Time frame: Through study completion, an average of 3 years

To assess the state of the autonomic function and cardiovascular control in patients undergoing CEA and check if there is a relation with the histological analysis of the carotid plaque after CEA.
Plaque vulnerability

Time frame: 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.

Sponsors and collaborators

Lead sponsor

IRCCS Policlinico S. Donato

Other

Collaborators

Ministry of Health, Italy
University of Pavia

Registry information

Acronym: PREDICT

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Oct 4, 2022
Registry last updated: Dec 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed