Clinical trial NCT04431609: Carotid Web Associated With Cerebral Infarctions
Official title: French Cohort of Carotid Web Associated With Cerebral Infarctions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carotid Arteries
Keywords: Carotid Web
Cerebral Infarction
Cohort
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients included and validated by the expert committee at the end of the inclusion period
timeFrame: At 3 years
Secondary outcomes:
measure: Demographics collected at the inclusion
timeFrame: at the inclusion
measure: NIHSS score at the admission in the neurological unit
timeFrame: at the inclusion
measure: Radiological of the cerebral infarction collected at the inclusion
timeFrame: Web measurements carried out by 2 experts one month after the inclusion
measure: Radiological of the cerebral infarction collected one month after the inclusion
timeFrame: Web measurements carried out by 2 experts one month after the inclusion
measure: Management of the cerebral infarction in emergency (within 48 hours from stroke onset): Thrombolysis, Thrombectomy, Decompressive hemicraniectomy, Antiplatelet or Anticoagulant treatment
timeFrame: at the inclusion
measure: Secondary preventive strategies applied between 2 and 90 days after stroke onset:- Number of patients treated -
timeFrame: at 3-month
measure: Secondary preventive strategies applied between 2 and 90 days after stroke onset:- Percentage of intracerebral hemorrhage and major systemic bleeding in patients treated -
timeFrame: at 3-month
measure: Stroke Outcome assessed with the Modified Rankin Scale score.
timeFrame: Between 3 to 6 months
measure: Incidence rates and delays of cerebrovascular events recurrence such as cerebral infarction or transient ischemic attack
timeFrame: From inclusion to the end of follow-up: 3 to 6 years
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
Study officials:
References: