Lectine Pathway in Unstable Carotid Plaque

Withdrawn

• Conditions: Mannose-Binding Lectin Complement Pathway; Carotid Artery Plaque
• Interventions: Procedure: Carotid endoarterectomy

• Registration Number: NCT03822195
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-01-07
• Study First Submitted QC: 2019-01-26
• Study First Posted: 2019-01-30
• Study Start: 2019-04-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-22
• Last Update Posted: 2020-07-24
• Primary Completion: 2021-01-31
• Study Completion: 2021-02-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
asymptomatic	Carotid endoarterectomy	asymptomatic patients undergoing carotid endoarterectomy for stenosis \>70% (velocimetric criteria at echodoppler)
symptomatic	Carotid endoarterectomy	symptomatic (TIA, crescendo TIA, minor stroke) patients undergoing carotid endoarterectomy, independently from stenosis evaluated by echodoppler

Primary Outcome Measures

Name	Time	Method
lectine pathway of complement activation in carotid plaques	preoperative	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.

Secondary Outcome Measures

Name	Time	Method
focal neurologic symptoms and plasmatic levels of complement activators	preoperative, postoperative day 3, 3 months after surgery	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
focal neurologic symptoms and histologic index of plaque instability	through study completion (average 1 year)	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).