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

Sponsor

Neuromed IRCCS (Other)

Overall Status

Recruiting

CT.gov ID

NCT03922698

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carotid Atherosclerosis	Other: No interventions

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 1, 2019

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Case Group 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	Other: No interventions No interventions - observational study

Arm

Intervention/Treatment

Case Group

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

Other: No interventions

No interventions - observational study

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.