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

NCT05190510 | Terminated

• 1 other identifier: STEINMETZ 2021
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• rate of 18FDG tracer uptake in carotid stenosis

  At baseline

• Degree of instability of the plate

  At baseline

Study Arms (1)

Patient with atheromatous stenosis of the internal carotid artery

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

Interventions

Data collection OTHER

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

Patient with atheromatous stenosis of the internal carotid artery

collection of the carotid plaque (surgical specimen) PROCEDURE

collection of the carotid plaque

Patient with atheromatous stenosis of the internal carotid artery

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

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

Patient with atheromatous stenosis of the internal carotid artery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Scheduled surgery

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

collection of the carotid plaque (surgical specimen)

MeSH Terms

Interventions

Data Collection; Cell Count; Gene Expression Profiling

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cell Physiological Phenomena; Genetic Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: January 13, 2022
• Study Start: February 14, 2022
• Primary Completion: January 26, 2023
• Study Completion: January 26, 2023
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

FR (1)