NCT05190510: EVA3M

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

Terminated Last updated 30 July 2024

What this trial tests

trial testing Data collection in Internal Carotid Artery in 12 participants. Terminated before completion.

Timeline

14 February 2022

Primary endpoint
26 January 2023

26 January 2023

Quick facts

Lead sponsor	Centre Hospitalier Universitaire Dijon
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	12
Start date	14 February 2022
Primary completion	26 January 2023
Estimated completion	26 January 2023
Sites	1 location across France

Drugs / interventions tested

• Data collection — full drug profile →
• collection of the carotid plaque (surgical specimen)
• anatomopathological, histological, cellular and molecular biology examinations (metabolomics and transcriptomics) on surgical specimens

Conditions studied

• Internal Carotid Artery — all drugs for Internal Carotid Artery →
• Atheromatous Stenosis — all drugs for Atheromatous Stenosis →

Sponsor

Centre Hospitalier Universitaire Dijon

Who can join

18 and older, any sex, with Internal Carotid Artery or Atheromatous Stenosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Emerging Role of Raman Spectroscopy as an Omics Approach for Metabolic Profiling and Biomarker Detection toward Precision Medicine.
   Cutshaw G, Uthaman S, Hassan N, Kothadiya S, et al · · 2023 · cited 95× · PMID 37318957 · DOI 10.1021/acs.chemrev.2c00897