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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ischemic Stroke
- Sponsor
- Yonsei University
- Enrollment
- 1359
- Locations
- 1
- Primary Endpoint
- Death
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •Age \<20 years old
- •Acute ischemic stroke patients who did not receive IV thrombolysis and/or IA recanalization treatment
- •No informed consents from patients
Outcomes
Primary Outcomes
Death
Time Frame: 6 months after discharge day
Recanalization rate
Time Frame: after 32 hrs thrombolytic treatments in MRA, CTA, or digital subtraction angiography (DSA)
asymptomatic hemorrhagic transformation rate
Time Frame: after 32 hrs thrombolysis in MR or CT
Modified Rankin scale scores
Time Frame: 3 months after discharge day
Symptomatic hemorrhagic transformation rate
Time Frame: after 32 hrs thrombolytic treatments in MR or CT
National Institutes of Health Stroke Scale (NIHSS) scores
Time Frame: 1 hr after IV rt-PA infusion