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

NCT ID: NCT05190510

Last Updated: 2024-07-30

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 12 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-14
• Study Completion Date: 2023-01-26

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.

Conditions

Internal Carotid Artery; Atheromatous Stenosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patient with atheromatous stenosis of the internal carotid artery

Data collection

Intervention Type: OTHER

Collection of data from preoperative imaging examinations (routine examination prescribed before the operation)

collection of the carotid plaque (surgical specimen)

Intervention Type: PROCEDURE

collection of the carotid plaque

anatomopathological, histological, cellular and molecular biology examinations (metabolomics and transcriptomics) on surgical specimens

Intervention Type: OTHER

anatomopathological, histological, cellular and molecular biology examinations (metabolomics and transcriptomics) on surgical specimens

Interventions

Data collection

Collection of data from preoperative imaging examinations (routine examination prescribed before the operation)

Intervention Type: OTHER

collection of the carotid plaque (surgical specimen)

collection of the carotid plaque

Intervention Type: PROCEDURE

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu Dijon Bourgogne

Dijon, , France

Countries

France

Other Identifiers

STEINMETZ 2021

Identifier Type: -

Identifier Source: org_study_id