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临床试验/NCT05475080
NCT05475080招募中不适用

Carotid Web and Stroke Registry. Clinical and Genetic Study. "Registro de Pacientes Con Carotid Web e Ictus. Estudio clínico y genético"

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年7月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Ischemic Recurrences

研究概览

简要总结

Introduction:

Carotid Web (CW) is a common cause of stroke in young patients with a high recurrence rate. The factors associated with recurrences and the appropriate treatment to prevent them are currently unknown.

Main objective:

To compare recurrences of ischemic stroke (cerebral infarction or transient ischemic attack) in patients with CW according to the preventive treatment.

Secondary objectives:

  • To describe the frequency of recurrences in patients with stroke and CW.
  • To compare the risk of complications, especially hemorrhagic complications, in patients with stroke and CW according to the type of preventive treatment given.
  • To describe the clinical and radiological characteristics of CW and identify which are associated with recurrences.
  • To detect genetic polymorphisms associated with the presence of CW in stroke patients.

Study design:

Multicenter, prospective registry of consecutive cases with ischemic stroke in which a Carotid Web is detected between 2022 and 2024.

All patients with ischemic stroke or transient ischemic attack and age > or = 18 years, in whom a Carotid Web is diagnosed, will be included. Demographic and clinical variables, genetic study (not mandatory), diagnostic methods of CW, reperfusion treatment and secondary prevention will be collected. During a minimum follow-up of six months, vascular events (stroke, transient ischemic accidents, cerebral hemorrhages) and treatments (antiplatelet therapy, anticoagulation, endarterectomy, endovascular therapy) will be collected.

Once the registry has been completed, the frequency of recurrences and the factors associated with them will be analyzed.

Study population:

Patients with ischemic stroke or transient ischemic attack in whom a Carotid Web is detected. It is estimated to obtain data from approximately 100 patients.

Variables:

Demographic, clinical (past medical history, stroke characteristics), radiological (diagnostic method of CW, morphological characteristics of CW), therapeutic (preventive treatment initiated) and prognostic variables will be collected. Recurrences in the form of stroke or transient ischemic attack (main variable) will be collected during a minimum follow-up of six months. Cerebral hemorrhages, mortality and therapeutic changes during follow-up will also be collected.

Ethical considerations:

This is an observational registry, with no changes in the management or treatment of the patients included, and with an anonymized data registry. Written informed consent will be requested from the patient or his/her representative for participation in the registry and for obtaining a blood sample for the genetic study.

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

入选标准

  • Patients with ischemic stroke or TIA and
  • Age > or = 18 years.
  • Carotid Web diagnosed by angioCT, angioMRI or arteriography.
  • Consent to participate from patient or representative

排除标准

  • No informed consent obtained

研究组 & 干预措施

Antiplatelet

干预措施: Antiplatelet Drug (Drug)

Anticoagulant

干预措施: Anticoagulant (Drug)

Endovascular

干预措施: Endovascular (Procedure)

Surgical (endarterectomy)

干预措施: Surgery (Procedure)

结局指标

主要结局

Ischemic Recurrences

时间窗: At least 6 months of follow-up

Stroke or TIA

次要结局

未报告次要终点

研究者

发起方
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
申办方类型
Other
责任方
Sponsor

研究点 (1)

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