NCT06887894

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Sep 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Sep 2019Dec 2027

Study Start

First participant enrolled

September 1, 2019

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2023

Completed
2 years until next milestone

First Posted

Study publicly available on registry

March 20, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

March 20, 2025

Status Verified

March 1, 2025

Enrollment Period

6.3 years

First QC Date

March 12, 2023

Last Update Submit

March 15, 2025

Conditions

Carotid Artery Diseases

Outcome Measures

Primary Outcomes (1)

  • miRNA levels

    miRNA levels and plaque vulnerability

    30 days

Interventions

Carotid endarterectomyPROCEDURE

Carotid endarterectomy, plaque histological analysis and miRNA expression

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM, 00167, Italy

RECRUITING

MeSH Terms

Conditions

Carotid Artery Diseases

Interventions

Endarterectomy, Carotid

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EndarterectomyVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Vascular Surgery

Study Record Dates

First Submitted

March 12, 2023

First Posted

March 20, 2025

Study Start

September 1, 2019

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2027

Last Updated

March 20, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)