Lectine Pathway in Unstable Carotid Plaque

Study Overview
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Brief Summary
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The study is aimed to investigate the possible role of lectin pathway - an alternative pathway of complement activation - in affecting stability of carotid atherosclerotic plaques and the possible correlations with clinical neurologic features.

Detailed Description
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In addition to the known hemodynamic criteria, instable carotid plaques can be responsible for brain ischemia, therefore is paramount to identify preoperatively possible markers of plaque instability. The study is aimed to investigate the possible role of lectin pathway - an alternative pathway of complement activation - in affecting stability of carotid atherosclerotic plaques and the possible correlations with clinical neurologic features. Study population will include 40 patients with internal carotid artery stenosis >=70% (assessed by echocolordoppler), symptomatic or asymptomatic, surgically treated by endoarterectomy. Removed plaques will be evaluated by histologic exam and immunofluorescence for ficolins 1-2-3 and Mannose Binding Lectin (MBL). Plasma samples will be used for ELISA test of lectin pathway complement activation.

Official Title
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Evaluation of Lectine Pathway in Assessment of Unstable Carotid Plaque

Conditions
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Carotid Artery Plaque, Mannose-Binding Lectin Complement Pathway

Intervention / Treatment
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* Procedure: Carotid endoarterectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergone elective or urgent carotid endoarterectomy (CEA) for internal carotid stenosis >70% (assessed by velocimetric criteria) with or without neurologic symptoms Exclusion Criteria: recent (<20 days) major/minor stroke with positive CT scan absolute contraindications to surgery (cardiac, respiratory, anesthesiologic risk)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| asymptomatic<br>asymptomatic patients undergoing carotid endoarterectomy for stenosis >70% (velocimetric criteria at echodoppler) | Procedure: Carotid endoarterectomy<br>* Surgical removal of carotid bifurcation plaque and arterial repair (direct suture or patch)<br>* Other names: CEA;|
| symptomatic<br>symptomatic (TIA, crescendo TIA, minor stroke) patients undergoing carotid endoarterectomy, independently from stenosis evaluated by echodoppler | Procedure: Carotid endoarterectomy<br>* Surgical removal of carotid bifurcation plaque and arterial repair (direct suture or patch)<br>* Other names: CEA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lectine pathway of complement activation in carotid plaques | assessment of association between plasmatic levels of complement activators and plaque instability (histologic index). Protein plasma levels will be assessed as optical density. Plaque instability will be quantified by a vulnerability score that combines four different histological parameters according to their quartile distribution (Fumagalli et al., Frontiers Immunology 2017). Their association will be analyzed as odds ratio (95%-CI) by a Fisher test. | preoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| focal neurologic symptoms and plasmatic levels of complement activators | Correlation of onset of focal neurologic symptoms (TIA, any stroke) due to carotid stenosis and peripheral plasma levels of complement activators. Neurological exam + CT or MNR will be used as clinical measurement tool | preoperative, postoperative day 3, 3 months after surgery | 
| focal neurologic symptoms and histologic index of plaque instability | correlation of onset of focal neurologic symptoms (TIA, any stroke) due to carotid stenosis and histologic index for plaque instability. Protein plasma levels will be assessed as optical density. Plaque instability will be quantified by a vulnerability score that combines four different histological parameters according to their quartile distribution (Fumagalli et al., Frontiers Immunology 2017). | through study completion (average 1 year) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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carotid artery atherosclerosis, alternative complement pathway