Potential Impact of Neuroimmune and Autophagic Alterations on the Progression and Severity of Human Atherosclerotic Process

• Conditions: Carotid Atherosclerosis
• Interventions: Other: No interventions

• Registration Number: NCT03922698
• Lead Sponsor: Neuromed IRCCS

Brief Summary

The hypothesis of this study is that neural regulations of the atherosclerotic plaque, identified in the murine model of atherosclerosis, could also exist in human pathology. The dysregulation status of the autonomic nervous system is typical of several cardiovascular diseases, but the role it exerts in the modulation of important mechanisms at the basis of the atherosclerotic process progression has not been investigated yet. The main aim of this study will be to investigate, in the atherosclerotic plaque, the alterations of inflammatory and immune processes, the neural modulations and the presence of dysregulations of the autophagic process. The investigators will also associate the potential presence of neural modulations of the plaque to its stability/instability, from a clinical-translational point of view. Finally, the investigators aim at providing a solid basis for the development of novel therapeutic strategies, which could reduce the elevated health and welfare costs for the clinical management of cardiovascular pathologies such as atherosclerosis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-17
• Study First Submitted QC: 2019-04-17
• Study First Posted: 2019-04-22
• Study Start: 2019-06-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-08
• Last Update Posted: 2022-04-11
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• age ≥ 45 and ≤ 90 years;
• patients with severe (70-99%) carotid stenosis, diagnosed with color doppler echography or angio-MRI or angiography;
• written informed consent.

Exclusion Criteria

• carotid stenosis <70% at carotid bifurcation or diagnosed with color doppler echography or angio-MRI or angiography;
• severe neoplasia;
• participation to other clinical trial, ongoing or terminated less than one month before enrolment in this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case Group	No interventions	Patients who undergo surgical intervention of carotid trombo-endo-arterectomy at the Department of Vascular Surgery of the IRCCS Neuromed, with specific inclusion/exclusion criteria

Primary Outcome Measures

Name	Time	Method
Characterization of the neuro-modulation of immune system in atherosclerosis	At enrollment	Immunohistochemistry and immunofluorescence of the autonomic nervous and immune systems in the atherosclerotic plaque, and flow cytometry analysis of circulating immune cells.
Characterization of the autophagic process and correlation with neural modulations of the stability/instability plaque	At enrollment	Expression of autophagic markers and immunohistochemical analysis of the atherosclerotic plaque.

Trial Locations

Locations (1)

IRCCS Neuromed; 🇮🇹 Pozzilli, Italy