Clinical trial NCT03922698: Potential Impact of Neuroimmune and Autophagic Alterations on the Progression and Severity of Human Atherosclerotic Process
Official title: Potential Impact of Neuroimmune and Autophagic Alterations on the Progression and Severity of Human Atherosclerotic Process
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carotid Atherosclerosis
Keywords: atherosclerotic plaque
autonomic nervous system
immune system
autophagy
Lead sponsor: Neuromed IRCCS
Sponsor class: OTHER
First posted: 2019-04-22
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Characterization of the neuro-modulation of immune system in atherosclerosis
timeFrame: At enrollment
measure: Characterization of the autophagic process and correlation with neural modulations of the stability/instability plaque
timeFrame: At enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Pozzilli
country: Italy
facility: IRCCS Neuromed
Study officials:
affiliation: IRCCS Neuromed
name: Giuseppe Lembo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS Neuromed
name: Giacomo Frati, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: