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

NCT ID: NCT03922698

Last Updated: 2022-04-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2022-06-30

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.

Conditions

Carotid Atherosclerosis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions

Intervention Type: OTHER

No interventions - observational study

Interventions

No interventions

No interventions - observational study

Intervention Type: OTHER

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neuromed IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Giuseppe Lembo

Full Professor, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giuseppe Lembo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Neuromed

Giacomo Frati, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Neuromed

Locations

IRCCS Neuromed

Pozzilli, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Giuseppe Lembo, MD, PhD

Role: CONTACT

lembo@neuromed.it

+39 0865915225

Facility Contacts

Giuseppe Lembo, MD, PhD

Role: primary

+39 0865915225

Other Identifiers

LMB06

Identifier Type: -

Identifier Source: org_study_id