Carotid Web Associated With Cerebral Infarctions

Carotid Arteries Clinical Trial

— CAROWEB  

Official title:

French Cohort of Carotid Web Associated With Cerebral Infarctions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04431609
• Other study ID #: CHUBX 2018/40
• Status: Recruiting
• Start date: June 19, 2019
• Est. completion date: June 30, 2026

Study information

• Verified date: October 2023
• Source: University Hospital, Bordeaux
• Contact: Stéphane OLINDO, M.D
• Phone: 05 57 82 12 63
• Email: stephane.olindo[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carotid Arteries
• Cerebral Infarction
• Infarction

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Demographics collected at the inclusion	Age, Sex, Ethnic group based on self-determination	at the inclusion
Secondary	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
Secondary	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
Secondary	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
Secondary	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	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	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
Secondary	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
Secondary	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