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

Terminated

• Conditions: Internal Carotid Artery; Atheromatous Stenosis
• Interventions: Other: Data collection; Procedure: collection of the carotid plaque (surgical specimen); Other: anatomopathological, histological, cellular and molecular biology examinations (metabolomics and transcriptomics) on surgical specimens

• Registration Number: NCT05190510
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-11
• Study First Submitted QC: 2021-12-29
• Study First Posted: 2022-01-13
• Study Start: 2022-02-14
• Primary Completion: 2023-01-26
• Study Completion: 2023-01-26
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient with atheromatous stenosis of the internal carotid artery	Data collection	-
Patient with atheromatous stenosis of the internal carotid artery	anatomopathological, histological, cellular and molecular biology examinations (metabolomics and transcriptomics) on surgical specimens	-
Patient with atheromatous stenosis of the internal carotid artery	collection of the carotid plaque (surgical specimen)	-

Primary Outcome Measures

Name	Time	Method
Degree of instability of the plate	At baseline
rate of 18FDG tracer uptake in carotid stenosis	At baseline

Trial Locations

Locations (1)

Chu Dijon Bourgogne; 🇫🇷 Dijon, France