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
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
- 否
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
