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临床试验/NCT02964052
NCT02964052已完成不适用

Selection Criteria in Endovascular Thrombectomy and Thrombolytic Therapy (SECRET) Study: Development of Patient Selection Criteria Using CT Images and Accompanying Diseases for Efficient Intravenous Thrombolytic and Intra-arterial Recanalization Therapy in Acute Ischemic Stroke

Yonsei University1 个研究点 分布在 1 个国家目标入组 1,359 人开始时间: 2016年11月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,359
试验地点
1
主要终点
Death

研究概览

简要总结

Use of intravenous (IV) thrombolysis and intra-arterial (IA) recanalization treatment has been rapidly increasing, However, despite of the treatment, recanalization rates are 22.6 - 70% and only 30-50% of patients show meaningful clinical improvements. Mechanisms of futile recanalization may include 1) large ischemic core, 2) poor collateral, and 3) presence of comorbidity. In this regards, developing selection criteria using acute stroke imaging and comorbidity is warranted.

Investigators will recruit the consecutive acute stroke patients who received IV thrombolysis and/or IA recanalization treatment. This study will perform with prospective design to develop CT-based clot, core and collateral scores and a comorbidity index for selecting stroke patients who are at high risks by the treatment. Investigators will firstly establish the CT-based scores and comorbidity index using a pre-existing cohort database. Using these CT-based and comorbidity index, Investigators will validate them in a multi-center prospectively cohort. In addition, Investigators will assess the cost-effectiveness of selecting patients based on the comorbidity index.

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
20 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥20 years old
  • Acute ischemic stroke patients who underwent CT angiographies before IV thrombolysis and/or IA recanalization treatment
  • Patients who give an informed consents for participation in the study or the legal representative or immediate family give informed consent on behalf of patients in case of difficulty to decide study enrollment.

排除标准

  • Age <20 years old
  • Acute ischemic stroke patients who did not receive IV thrombolysis and/or IA recanalization treatment
  • No informed consents from patients

结局指标

主要结局

Death

时间窗: 6 months after discharge day

Recanalization rate

时间窗: after 32 hrs thrombolytic treatments in MRA, CTA, or digital subtraction angiography (DSA)

asymptomatic hemorrhagic transformation rate

时间窗: after 32 hrs thrombolysis in MR or CT

Modified Rankin scale scores

时间窗: 3 months after discharge day

Symptomatic hemorrhagic transformation rate

时间窗: after 32 hrs thrombolytic treatments in MR or CT

National Institutes of Health Stroke Scale (NIHSS) scores

时间窗: 1 hr after IV rt-PA infusion

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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