French Cohort of Carotid Web Associated With Cerebral Infarctions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Number of patients included and validated by the expert committee at the end of the inclusion period
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Age <18 years
- •Patient expressing opposition to be enrolled in the CAROWEB cohort
结局指标
主要结局
Number of patients included and validated by the expert committee at the end of the inclusion period
时间窗: 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.
次要结局
- Secondary preventive strategies applied between 2 and 90 days after stroke onset:- Number of patients treated -(at 3-month)
- NIHSS score at the admission in the neurological unit(at the inclusion)
- Demographics collected at the inclusion(at the inclusion)
- Radiological of the cerebral infarction collected at the inclusion(Web measurements carried out by 2 experts one month after the inclusion)
- Radiological of the cerebral infarction collected one month after the inclusion(Web measurements carried out by 2 experts one month after the inclusion)
- Stroke Outcome assessed with the Modified Rankin Scale score.(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)
- Management of the cerebral infarction in emergency (within 48 hours from stroke onset): Thrombolysis, Thrombectomy, Decompressive hemicraniectomy, Antiplatelet or Anticoagulant treatment(at the inclusion)
- 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)