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

NCT03922698 | Unknown

• 1 other identifier: LMB06
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Atherosclerosis

Keywords

atherosclerotic plaque; autonomic nervous system; immune system; autophagy

Outcome Measures

Primary Outcomes (2)

• Characterization of the neuro-modulation of immune system in atherosclerosis

  Immunohistochemistry and immunofluorescence of the autonomic nervous and immune systems in the atherosclerotic plaque, and flow cytometry analysis of circulating immune cells.

  At enrollment

• Characterization of the autophagic process and correlation with neural modulations of the stability/instability plaque

  Expression of autophagic markers and immunohistochemical analysis of the atherosclerotic plaque.

  At enrollment

Study Arms (1)

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

Interventions

No interventions OTHER

No interventions - observational study

Case Group

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects will be selected from patients who will undergo to surgical intervention of carotid trombo-endo-arterectomy at the Department of Vascular Surgery of the IRCCS Neuromed, accordingly to the following inclusion/exclusion criteria. Approximately 50 subjects of both genders will be included in the study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neuromed IRCCS: lead

Study Sites (1)

IRCCS Neuromed

Pozzilli, 86077, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood and serum, bioptic tissue (atherosclerotic plaque)

MeSH Terms

Conditions

Carotid Artery Diseases; Plaque, Atherosclerotic

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Giuseppe Lembo, MD, PhD

  IRCCS Neuromed

  PRINCIPAL INVESTIGATOR

• Giacomo Frati, MD, PhD

  IRCCS Neuromed

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuseppe Lembo, MD, PhD

CONTACT

+39 0865915225; lembo@neuromed.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor, MD, PhD

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: April 22, 2019
• Study Start: June 1, 2019
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: April 11, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)