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出境医 / 临床实验 / 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

Study Description
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.

Condition or disease Intervention/treatment
Carotid Atherosclerosis Other: No interventions

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Potential Impact of Neuroimmune and Autophagic Alterations on the Progression and Severity of Human Atherosclerotic Process
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020
Arms and Interventions
Group/Cohort Intervention/treatment
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
No interventions - observational study
Outcome Measures
Primary Outcome Measures :
  1. Characterization of the neuro-modulation of immune system in atherosclerosis [ Time Frame: At enrollment ]
    Immunohistochemistry and immunofluorescence of the autonomic nervous and immune systems in the atherosclerotic plaque, and flow cytometry analysis of circulating immune cells.

  2. Characterization of the autophagic process and correlation with neural modulations of the stability/instability plaque [ Time Frame: At enrollment ]
    Expression of autophagic markers and immunohistochemical analysis of the atherosclerotic plaque.


Biospecimen Retention:   Samples Without DNA
Whole blood and serum, bioptic tissue (atherosclerotic plaque)

Eligibility Criteria
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Ages Eligible for Study:   45 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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.
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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Giuseppe Lembo, MD, PhD +39 0865915225 lembo@neuromed.it

Locations
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Italy
IRCCS Neuromed Recruiting
Pozzilli, Italy, 86077
Contact: Giuseppe Lembo, MD, PhD    +39 0865915225      
Principal Investigator: Giuseppe Lembo, MD, PhD         
Principal Investigator: Giacomo Frati, MD, PhD         
Sub-Investigator: Daniela Carnevale, PhD         
Sub-Investigator: Francesco Pompeo, MD         
Sub-Investigator: Alessandro Landolfi, MD         
Sponsors and Collaborators
Neuromed IRCCS
Investigators
Layout table for investigator information
Principal Investigator: Giuseppe Lembo, MD, PhD IRCCS Neuromed
Principal Investigator: Giacomo Frati, MD, PhD IRCCS Neuromed
Tracking Information
First Submitted Date April 17, 2019
First Posted Date April 22, 2019
Last Update Posted Date September 10, 2020
Actual Study Start Date June 1, 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 17, 2019)
  • Characterization of the neuro-modulation of immune system in atherosclerosis [ Time Frame: At enrollment ]
    Immunohistochemistry 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 plaque [ Time Frame: At enrollment ]
    Expression of autophagic markers and immunohistochemical analysis of the atherosclerotic plaque.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Whole blood and serum, bioptic tissue (atherosclerotic plaque)
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.
Condition Carotid Atherosclerosis
Intervention Other: No interventions
No interventions - observational study
Study Groups/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
Intervention: Other: No interventions
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 17, 2019) 		50
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 45 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Giuseppe Lembo, MD, PhD +39 0865915225 lembo@neuromed.it
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT03922698
Other Study ID Numbers LMB06
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Giuseppe Lembo, Neuromed IRCCS
Study Sponsor Neuromed IRCCS
Collaborators Not Provided
Investigators
Principal Investigator: Giuseppe Lembo, MD, PhD IRCCS Neuromed
Principal Investigator: Giacomo Frati, MD, PhD IRCCS Neuromed
PRS Account Neuromed IRCCS
Verification Date September 2020

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