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

Carotid Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03922698
• Other study ID #: LMB06
• Status: Recruiting
• Start date: June 1, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: April 2022
• Source: Neuromed IRCCS
• Contact: Giuseppe Lembo, MD, PhD
• Phone: +39 0865915225
• Email: lembo[@]neuromed.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atherosclerosis
• Carotid Artery Diseases
• Carotid Atherosclerosis

Intervention

Other:
• No interventions
No interventions - observational study

Locations

Country	Name	City	State
Italy	IRCCS Neuromed	Pozzilli

Sponsors (1)

Lead Sponsor	Collaborator
Neuromed IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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