Biomarkers and Unstable Carotid Plaque

March 15, 2025 updated by: TINELLI GIOVANNI, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

EVALUATION OF NEW BIOMARKERS IN THE IDENTIFICATION OF UNSTABLE CAROTID PLAQUE

This prospective study investigated associations between circulating miRNAs and symptomatic and asymptomatic ICAS, carotid plaque morphology and future cardiovascular events.

Study Overview

Status

Recruiting

Conditions

Carotid Artery Diseases

Intervention / Treatment

Procedure: Carotid endarterectomy

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Italy
- RM
  - Roma, RM, Italy, 00167
    - Recruiting
    - Fondazione Policlinico Universitario A. Gemelli IRCCS
    - Contact:
      
      Giovanni Tinelli
      
      Phone Number: 0039 0630157205
      
      Email: giovanni.tinelli@policlinicogemelli.it

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

All the patients with significant internal carotid artery stenosis referred to the Unit of Vascular Surgery of Fondazione Policlinico Gemelli IRCCS Rome for carotid artery endoarterectomy.

Description

Inclusion Criteria:

Presence of significant internal carotid artery stenosis referred to carotid artery endarterectomy.
Age>18 years

Exclusion Criteria:

Presence of significant internal carotid artery stenosis referred to carotid artery stenting

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
miRNA levels Time Frame: 30 days	miRNA levels and plaque vulnerability	30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

March 12, 2023

First Submitted That Met QC Criteria

March 15, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)