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Lectine Pathway in Unstable Carotid Plaque

Evaluation of Lectine Pathway in Assessment of Unstable Carotid Plaque

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03822195
Enrollment
0
Registered
2019-01-30
Start date
2019-04-01
Completion date
2021-02-28
Last updated
2020-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carotid Artery Plaque, Mannose-Binding Lectin Complement Pathway

Keywords

carotid artery atherosclerosis, alternative complement pathway

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.

Interventions

Surgical removal of carotid bifurcation plaque and arterial repair (direct suture or patch)

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
lectine pathway of complement activation in carotid plaquespreoperativeassessment 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

MeasureTime frameDescription
focal neurologic symptoms and plasmatic levels of complement activatorspreoperative, postoperative day 3, 3 months after surgeryCorrelation 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 instabilitythrough 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).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026