Skip to content

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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03922698
Enrollment
50
Registered
2019-04-22
Start date
2019-06-01
Completion date
2022-06-30
Last updated
2022-04-11

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

Conditions

Carotid Atherosclerosis

Keywords

atherosclerotic plaque, autonomic nervous system, immune system, autophagy

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.

Interventions

OTHERNo interventions

No interventions - observational study

Sponsors

Neuromed IRCCS
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
45 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Characterization of the neuro-modulation of immune system in atherosclerosisAt enrollmentImmunohistochemistry 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 plaqueAt enrollmentExpression of autophagic markers and immunohistochemical analysis of the atherosclerotic plaque.

Countries

Italy

Contacts

Primary ContactGiuseppe Lembo, MD, PhD
lembo@neuromed.it+39 0865915225

Outcome results

None listed

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