EVA3M: Assessment of Vulnerability to Carotid Stenosis by MultiModal Imaging and Cellular and Molecular Biology Analysis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patient with atheromatous stenosis of the internal carotid artery
|
Other: Data collection
Collection of data from preoperative imaging examinations (routine examination prescribed before the operation)
Procedure: collection of the carotid plaque (surgical specimen)
collection of the carotid plaque
Other: 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
|
Outcome Measures
Primary Outcome Measures
- rate of 18FDG tracer uptake in carotid stenosis [At baseline]
- Degree of instability of the plate [At baseline]
Eligibility Criteria
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
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with contraindication to PET scan
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with a history of cervical radiotherapy
-
with uncontrolled diabetes
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with a previous homolateral carotid endarterectomy
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who has already undergone angioplasty-stenting of the homolateral carotid artery
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with a neoplasia considered active / not cured
-
Surgical procedure performed in emergency
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chu Dijon Bourgogne | Dijon | France | 21000 |
Sponsors and Collaborators
- Centre Hospitalier Universitaire Dijon
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STEINMETZ 2021