ClinicalTrials.gg
Status unknownNCT03922698Updated Apr 11, 2022

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

An observational study in Carotid Atherosclerosis, sponsored by Neuromed IRCCS. Status unknown at 1 site in Italy. Open to participants aged 45 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-04-11.

Sponsored by Neuromed IRCCS · Observational

The sponsor has not verified this record recently (last verified Apr 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
50
Ages
45 Years to 90 Years
Sex
All
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Study 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.

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Conditions studied

  • Carotid Atherosclerosis

Keywords

  • atherosclerotic plaque
  • autonomic nervous system
  • immune system
  • autophagy
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In context

Carotid Artery Diseases

257 studies on the registry are indexed under Carotid Artery Diseases; 58 are open to participants now.

This study's planned enrollment of 50 is below the median of 224 across 112 observational studies indexed under Carotid Artery Diseases.

Browse Carotid Artery Diseases studies →

Lead sponsor

Neuromed IRCCS is the lead sponsor of 79 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
45 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • OtherNo interventions

    No interventions - observational study

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: At enrollment

  2. 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.

    Time frame: At enrollment

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Study locations

1 of 1 sites recruiting
  • IRCCS Neuromed
    Pozzilli, 86077, Italy
    • Giuseppe Lembo, MD, PhD · Contact · +39 0865915225
    • Giuseppe Lembo, MD, PhD · Principal investigator
    • Giacomo Frati, MD, PhD · Principal investigator
    • Daniela Carnevale, PhD · Sub investigator
    • Francesco Pompeo, MD · Sub investigator
    • Alessandro Landolfi, MD · Sub investigator
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03922698
Lead sponsor
Neuromed IRCCS
Responsible party
Giuseppe Lembo (Full Professor, MD, PhD, Neuromed IRCCS) — Principal investigator
First posted
Apr 22, 2019
Start date
Jun 1, 2019
Primary completion
Jun 30, 2022 (estimated)
Completion
Jun 30, 2022 (estimated)
Last update
Apr 11, 2022

Study contacts

Giuseppe Lembo, MD, PhD
Contact
lembo@neuromed.it
+39 0865915225
Giuseppe Lembo, MD, PhD
principal investigator · IRCCS Neuromed
Giacomo Frati, MD, PhD
principal investigator · IRCCS Neuromed

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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