Assessment of Vulnerability to Carotid Stenosis by MultiModal Imaging and Cellular and Molecular Biology Analysis (EVA3M)

July 29, 2024 updated by: Centre Hospitalier Universitaire Dijon

Assessment of Vulnerability to Carotid Stenosis by MultiModal Imaging and Cellular and Molecular Biology Analysis Pilot Study

Cerebrovascular accidents (CVA) are the second leading cause of death in France, and the most frequent cause of acquired physical and mental disability. Up to 90% of strokes are ischemic, among which about 15% are due to the presence of stenosis of the carotid sinus, at the base of the extracranial internal carotid artery.

For many years, only the degree of stenosis was used to assess the risk of stroke, based on the results of original studies from the 1990s. However, the significant improvement in medical treatments since then has significantly reduced the risk of stroke, and the benefits of carotid intervention are becoming increasingly debatable.

Since the publication of the latest recommendations, the degree of stenosis alone is no longer sufficient to propose an intervention, since most of them will never lead to a neurological event. In addition to stenosis greater than 60%, for the first time, other criteria must be sought to decide on treatment. For example, so-called carotid plaque "vulnerability" criteria, defining patients "at high risk of stroke," should be sought.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

12

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

  • France
      • Dijon, France, 21000
        • Chu Dijon Bourgogne

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Scheduled surgery

Description

Inclusion Criteria:

  • Patients with symptomatic or asymptomatic atheromatous stenosis of the internal carotid artery, of a degree ≥ 50%, for which an operative indication is retained
  • Scheduled surgery

Exclusion Criteria:

Samples collected from patients :

  • who did not have a preoperative CT angiogram of the supra-aortic trunks
  • with contraindication to MRI
  • with contraindication to PET scan
  • with a history of cervical radiotherapy
  • with uncontrolled diabetes
  • with a previous homolateral carotid endarterectomy
  • who has already undergone angioplasty-stenting of the homolateral carotid artery
  • with a neoplasia considered active / not cured
  • Surgical procedure performed in emergency

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient with atheromatous stenosis of the internal carotid artery
Other: Data collection
Collection of data from preoperative imaging examinations (routine examination prescribed before the operation)
Procedure: collection of the carotid plaque (surgical specimen)
collection of the carotid plaque
Other: anatomopathological, histological, cellular and molecular biology examinations (metabolomics and transcriptomics) on surgical specimens
anatomopathological, histological, cellular and molecular biology examinations (metabolomics and transcriptomics) on surgical specimens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
rate of 18FDG tracer uptake in carotid stenosis
Time Frame: At baseline
At baseline
Degree of instability of the plate
Time Frame: At baseline
At baseline

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire Dijon

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)

February 14, 2022

Primary Completion (Actual)

January 26, 2023

Study Completion (Actual)

January 26, 2023

Study Registration Dates

First Submitted

October 11, 2021

First Submitted That Met QC Criteria

December 29, 2021

First Posted (Actual)

January 13, 2022

Study Record Updates

Last Update Posted (Actual)

July 30, 2024

Last Update Submitted That Met QC Criteria

July 29, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STEINMETZ 2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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