Carotid Web Associated With Cerebral Infarctions

Recruiting

• Conditions: Carotid Arteries

• Registration Number: NCT04431609
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

Carotid Web located at the bulb level is a rare condition and is often associated with severe cerebral infarction in the carotid territory. This condition has been described predominantly in the black population. However, limited data are available for the epidemiology of carotid web and often result from selected population studies. It has been shown that the carotid web is a focal intimal dysplasia. Rate of ischemic stroke recurrence is high, even in patients treated with antiplatelet therapy. This subtle lesion is often unknown and misdiagnosed including in stroke unit. We assume that the implementation of a multicentric cohort would allow a comprehensive analysis of the carotid web condition.

Detailed Description

Carotid web lesions associated with cerebral infarctions are a relatively rare and largely unknown disease. However, carotid web lesions are associated with severe infarction involving the functional and vital prognosis of patients. The high rate of recurrence should lead to an identification of the lesion at the first event in order to propose a suitable preventive treatment. We believe that only a multicenter cohort will be able to analyze the characteristics of the pathology and propose studies on critical size samples. A national cohort would lead quickly to a consequent collection of cases. By including overseas departments and communities, notions of prevalence and characteristics within different populations could finally be studied. Participation to the cohort constitution will probably lead to sensitizing the various actors of the course of stroke care to the diagnosis and appropriate care of the carotid web.

Patients will be selected by the Stroke Units which take part in the cohort constitution. Stroke Unit investigator will fill the WEPI online entry database. Clinical, imaging and outcome characteristics will be informed.

In order to guarantee the quality of the cases collected, the validation of the carotid web lesion will be carried out by a pair of expert Neurologist - Neuroradiologist appointed within an expert committee. In case of no consensus, a third expert will resolve the disagreement.

Study Timeline

• Study Start: 2019-06-19
• Study First Submitted: 2020-01-30
• Study First Submitted QC: 2020-06-12
• Study First Posted: 2020-06-16
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-05
• Last Update Posted: 2023-10-06
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Age ≥18 years
• Available imaging revealing the presence of a carotid web
• Cerebral infarction or transient ischemic attack in the carotid area downstream of a carotid web lesion.
• Validation of the carotid web by a pair of experts Neurologist and Neuroradiologist
• Agreement of the patient or the support person given after reading the information and non-opposition form

Exclusion Criteria

• Age <18 years
• Patient expressing opposition to be enrolled in the CAROWEB cohort

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients included and validated by the expert committee at the end of the inclusion period	At 3 years	The missing data concerning clinical data, therapy used and functional prognosis between 3 and 6 months should be \<10%. Each item entered in the eCRF can be answered. The lack of response will be considered as missing data in the patient's file.

Secondary Outcome Measures

Name	Time	Method
Secondary preventive strategies applied between 2 and 90 days after stroke onset:- Number of patients treated -	at 3-month	- Number of patients treated with: 1) Antiplatelet treatment alone, 2) Anticoagulant treatment alone, 3) Endarterectomy and excision of the Web, 4) Carotid artery stenting
NIHSS score at the admission in the neurological unit	at the inclusion	NIHSS scale (National Institute of Health Stroke Score) was described by T. Brott, in 1989, for used to assess patients with acute ischemic stroke. It can be used in carotid and vertebrobasilar ischemic attacks. The passing time of the scale is 6 minutes 30 on average. The NIHSS Score ranges from 0 to 42. A higher score indicates a worse clinical status.
Demographics collected at the inclusion	at the inclusion	Age, Sex, Ethnic group based on self-determination
Radiological of the cerebral infarction collected at the inclusion	Web measurements carried out by 2 experts one month after the inclusion	localization and extent of the infarction on the cerebral MRI and Radiological of the carotid Web: Uni or bilaterality,
Radiological of the cerebral infarction collected one month after the inclusion	Web measurements carried out by 2 experts one month after the inclusion	localization and extent of the infarction on the cerebral MRI and Radiological of the carotid Web: Uni or bilaterality,
Stroke Outcome assessed with the Modified Rankin Scale score.	Between 3 to 6 months	The Modified Rankin Scale (MRS) is a single item overall outcome assessment scale for post-stroke patients. It is used to categorize the level of functional independence based on pre-stroke activities rather than on observing performance while performing a specific task. A higher score (range from 0 to 6) indicates a poorer outcome.
Incidence rates and delays of cerebrovascular events recurrence such as cerebral infarction or transient ischemic attack	From inclusion to the end of follow-up: 3 to 6 years
Management of the cerebral infarction in emergency (within 48 hours from stroke onset): Thrombolysis, Thrombectomy, Decompressive hemicraniectomy, Antiplatelet or Anticoagulant treatment	at the inclusion	Number of patients treated with: 1) Thrombolysis, 2) Mechanical Thrombectomy, 3) Decompressive hemicraniectomy, 4) Antiplatelet treatment, 5) Anticoagulant treatment
Secondary preventive strategies applied between 2 and 90 days after stroke onset:- Percentage of intracerebral hemorrhage and major systemic bleeding in patients treated -	at 3-month	- Percentage of intracerebral hemorrhage and major systemic bleeding in patients treated with: 1) Antiplatelet treatment alone, 2) Anticoagulant treatment alone, 3) Endarterectomy and excision of the Web, 4) Carotid artery stenting; * Intracerebral hemorrhage has to be proven by a brain CT Scan or MRI.; * Major systemic bleeding is defined according to Schulman et al., Journal of thrombosis and haemostasis, 2005.

Trial Locations

Locations (1)

CHU de Bordeaux; 🇫🇷 Bordeaux, France