Carotid Web Associated With Cerebral Infarctions (CAROWEB)

French Cohort of Carotid Web Associated With Cerebral Infarctions

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.

Study Overview

• Status: Recruiting
• Conditions: Carotid Arteries

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 Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Stéphane OLINDO, M.D; Phone Number: 05 57 82 12 63; Email: stephane.olindo@chu-bordeaux.fr
• Study Contact Backup: Name: Aurore CAPELLI, PhD; Phone Number: 05 57 82 08 77; Email: aurore.capelli@chu-bordeaux.fr

Study Locations

• France
  • Bordeaux, France, 33076
    • Recruiting
    • CHU de Bordeaux
    • Contact: Stéphane OLINDO, MD; Phone Number: 05 57 82 12 63; Email: stephane.olindo@chu-bordeaux.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients over 18 years of age, with imagery available by Angioscanner, Angio-MRI, or arteriography and revealing the presence of a carotid web, with a cerebral infarction or transient ischemic attack in the carotid territory downstream of a lesion of carotid web viewed on a brain MRI.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
CAROtid WEB associated with cerebral infarction; french multicentric cohort that collects retrospectively and prospectively purely observational data on patients with cerebral infarction associated with a carotid web. Diagnostic, therapeutic or follow-up strategies will be at the discretion of the Stroke Unit taking care of the patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients included and validated by the expert committee at the end of the inclusion period	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.	At 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographics collected at the inclusion	Age, Sex, Ethnic group based on self-determination	at the inclusion
NIHSS score at the admission in the neurological unit	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.	at the inclusion
Radiological of the cerebral infarction collected at the inclusion	localization and extent of the infarction on the cerebral MRI and Radiological of the carotid Web: Uni or bilaterality,	Web measurements carried out by 2 experts one month after the inclusion
Radiological of the cerebral infarction collected one month after the inclusion	localization and extent of the infarction on the cerebral MRI and Radiological of the carotid Web: Uni or bilaterality,	Web measurements carried out by 2 experts one month after the inclusion
Management of the cerebral infarction in emergency (within 48 hours from stroke onset): Thrombolysis, Thrombectomy, Decompressive hemicraniectomy, Antiplatelet or Anticoagulant treatment	Number of patients treated with: 1) Thrombolysis, 2) Mechanical Thrombectomy, 3) Decompressive hemicraniectomy, 4) Antiplatelet treatment, 5) Anticoagulant treatment	at the inclusion
Secondary preventive strategies applied between 2 and 90 days after stroke onset:- Number of patients treated -	- Number of patients treated with: 1) Antiplatelet treatment alone, 2) Anticoagulant treatment alone, 3) Endarterectomy and excision of the Web, 4) Carotid artery stenting	at 3-month
Secondary preventive strategies applied between 2 and 90 days after stroke onset:- Percentage of intracerebral hemorrhage and major systemic bleeding in patients treated -	- 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.	at 3-month
Stroke Outcome assessed with the Modified Rankin Scale score.	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.	Between 3 to 6 months
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

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2019
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: January 30, 2020
• First Submitted That Met QC Criteria: June 12, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Cohort; Cerebral Infarction; Carotid Web
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Stroke; Brain Infarction; Infarction; Cerebral Infarction
• Other Study ID Numbers: CHUBX 2018/40

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No