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

Diagnosis Clinical Trial

— PREDICT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05566080
• Other study ID #: GR-2018-12366862
• Status: Completed
• Start date: March 15, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: December 2023
• Source: IRCCS Policlinico S. Donato
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carotid Artery Plaque
• Carotid Stenosis
• Constriction, Pathologic
• Diagnosis

Intervention

Procedure:
• Carotid endarterectomy
Patients who have a significant carotid stenosis and who undergo surgical carotid endarterectomy

Locations

Country	Name	City	State
Italy	IRCCS Policlinico San Donato	San Donato Milanese	Milan

Sponsors (3)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Donato	Ministry of Health, Italy, University of Pavia

Country where clinical trial is conducted

Italy, 

References & Publications (13)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: J Vasc Surg. 2012 Mar;55(3):894. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Int J Stroke. 2016 Jul;11(5):NP62. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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