Actively Recruiting

Age: 18Years +
All Genders
ID06887894

Evaluation of New Biomarkers in the Identification of Unstable Carotid Plaque

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-03-20

200

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the link between circulating microRNAs (miRNAs) and carotid artery disease, focusing on both symptomatic and asymptomatic internal carotid artery stenosis (ICAS). The study aims to evaluate new biomarkers that could help identify unstable carotid plaques, which are associated with future cardiovascular events. This observational research is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Participants in this study undergo carotid endarterectomy, a surgical procedure to remove plaque from the carotid artery. During the procedure, plaque samples are collected and analyzed for histological characteristics and miRNA expression. This helps researchers understand the relationship between plaque features and circulating miRNAs. Throughout the study, researchers measure miRNA levels 30 days after the procedure. Participants are monitored to assess the correlation between miRNA expression, plaque instability, and cardiovascular outcomes. This study involves adult participants with significant carotid artery stenosis who are referred for carotid endarterectomy. The overall goal is to improve detection and prediction of unstable plaques to better manage carotid artery disease.

CONDITIONS

Brief Title

Biomarkers and Unstable Carotid Plaque

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Presence of significant internal carotid artery stenosis referred to carotid artery endarterectomy
  • Age over 18 years
Not Eligible

You will not qualify if you...

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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - 1 day

Participants undergo carotid endarterectomy, including plaque removal and analysis.

1 surgical visit (in-person)

Post-operative Follow-up

Duration - 30 days

Participants are monitored for miRNA levels and recovery following surgery.

Approximately 2 follow-up visits (in-person)

Trial Site Locations

Total: 1 location

1

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM, Italy, 00167

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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