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

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05190510
Acronym
EVA3M
Enrollment
12
Registered
2022-01-13
Start date
2022-02-14
Completion date
2023-01-26
Last updated
2024-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atheromatous Stenosis, Internal Carotid Artery

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.

Interventions

OTHERData collection

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

PROCEDUREcollection of the carotid plaque (surgical specimen)

collection of the carotid plaque

OTHERanatomopathological, 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

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
rate of 18FDG tracer uptake in carotid stenosisAt baseline
Degree of instability of the plateAt baseline

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026