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

NCT05566080 | Completed DMC

• 1 other identifier: GR-2018-12366862
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Artery Plaque; Diagnosis

Keywords

carotid stenosis; ultrasonic imaging; finite element analysis

Outcome Measures

Primary Outcomes (3)

• Plaque vulnerability

  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.

  Through study completion, an average of 3 years

• Plaque vulnerability

  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.

  Through study completion, an average of 3 years

• Plaque vulnerability

  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.

  Through study completion, an average of 3 years

Interventions

Carotid endarterectomy PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• age above 18 years;
• signed informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead
• University of Pavia: collaborator
• Ministry of Health, Italy: collaborator

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, Milan, 20097, Italy

Location

Related Publications (13)

• Kolos I, Troitskiy A, Balakhonova T, Shariya M, Skrypnik D, Tvorogova T, Deev A, Boytsov S; Aggressive Medical Treatment Evaluation for Asymptomatic Carotid Artery Stenosis (AMTEC) Study Group. Modern medical treatment with or without carotid endarterectomy for severe asymptomatic carotid atherosclerosis. J Vasc Surg. 2015 Oct;62(4):914-22. doi: 10.1016/j.jvs.2015.05.005.

  PMID: 26410046 BACKGROUND

• Spence JD. Endarterectomy vs. stenting vs. medical therapy. Int J Stroke. 2016 Jul;11(5):500-1. doi: 10.1177/1747493016643552. Epub 2016 Apr 11.

  PMID: 27256474 BACKGROUND

• Gupta A, Baradaran H, Schweitzer AD, Kamel H, Pandya A, Delgado D, Dunning A, Mushlin AI, Sanelli PC. Carotid plaque MRI and stroke risk: a systematic review and meta-analysis. Stroke. 2013 Nov;44(11):3071-7. doi: 10.1161/STROKEAHA.113.002551. Epub 2013 Aug 29.

  PMID: 23988640 BACKGROUND

• Huibers A, de Borst GJ, Wan S, Kennedy F, Giannopoulos A, Moll FL, Richards T. Non-invasive Carotid Artery Imaging to Identify the Vulnerable Plaque: Current Status and Future Goals. Eur J Vasc Endovasc Surg. 2015 Nov;50(5):563-72. doi: 10.1016/j.ejvs.2015.06.113. Epub 2015 Aug 19.

  PMID: 26298222 BACKGROUND

• AlMuhanna K, Hossain MM, Zhao L, Fischell J, Kowalewski G, Dux M, Sikdar S, Lal BK. Carotid plaque morphometric assessment with three-dimensional ultrasound imaging. J Vasc Surg. 2015 Mar;61(3):690-7. doi: 10.1016/j.jvs.2014.10.003. Epub 2014 Dec 9.

  PMID: 25499716 BACKGROUND

• Mahmood B, Ewertsen C, Carlsen J, Nielsen MB. Ultrasound Vascular Elastography as a Tool for Assessing Atherosclerotic Plaques - A Systematic Literature Review. Ultrasound Int Open. 2016 Nov;2(4):E106-E112. doi: 10.1055/s-0042-115564. Epub 2016 Oct 13.

  PMID: 27896334 BACKGROUND

• Tsekouras NS, Katsargyris A, Skrapari I, Bastounis EE, Georgopoulos S, Klonaris C, Bakoyiannis C, Bastounis EA. The role of carotid plaque echogenicity in baroreflex sensitivity. J Vasc Surg. 2011 Jul;54(1):93-9. doi: 10.1016/j.jvs.2010.11.121. Epub 2011 Mar 31.

  PMID: 21458208 BACKGROUND

• Ricotta JJ, Aburahma A, Ascher E, Eskandari M, Faries P, Lal BK; Society for Vascular Surgery. Updated Society for Vascular Surgery guidelines for management of extracranial carotid disease. J Vasc Surg. 2011 Sep;54(3):e1-31. doi: 10.1016/j.jvs.2011.07.031.

  PMID: 21889701 BACKGROUND

• Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.

  PMID: 8598068 BACKGROUND

• Pagani M, Montano N, Porta A, Malliani A, Abboud FM, Birkett C, Somers VK. Relationship between spectral components of cardiovascular variabilities and direct measures of muscle sympathetic nerve activity in humans. Circulation. 1997 Mar 18;95(6):1441-8. doi: 10.1161/01.cir.95.6.1441.

  PMID: 9118511 BACKGROUND

• van Engelen A, Wannarong T, Parraga G, Niessen WJ, Fenster A, Spence JD, de Bruijne M. Three-dimensional carotid ultrasound plaque texture predicts vascular events. Stroke. 2014 Sep;45(9):2695-701. doi: 10.1161/STROKEAHA.114.005752. Epub 2014 Jul 17.

  PMID: 25034714 BACKGROUND

• Sadat U, Li ZY, Young VE, Graves MJ, Boyle JR, Warburton EA, Varty K, O'Brien E, Gillard JH. Finite element analysis of vulnerable atherosclerotic plaques: a comparison of mechanical stresses within carotid plaques of acute and recently symptomatic patients with carotid artery disease. J Neurol Neurosurg Psychiatry. 2010 Mar;81(3):286-9. doi: 10.1136/jnnp.2009.190363. Epub 2009 Nov 25.

  PMID: 19939857 BACKGROUND

• Simel DL, Samsa GP, Matchar DB. Likelihood ratios with confidence: sample size estimation for diagnostic test studies. J Clin Epidemiol. 1991;44(8):763-70. doi: 10.1016/0895-4356(91)90128-v.

  PMID: 1941027 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

carotid atherosclerotic plaque

MeSH Terms

Conditions

Carotid Stenosis; Disease

Interventions

Endarterectomy, Carotid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Endarterectomy; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: October 4, 2022
• Study Start: March 15, 2021
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: December 28, 2023

Record last verified: 2023-12

Locations

IT (1)