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

Completed

• Conditions: Ischemic Stroke
• Interventions: Other: Brain CT imaging

• Registration Number: NCT02964052
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-07
• Study First Submitted QC: 2016-11-10
• Study First Posted: 2016-11-15
• Study Start: 2016-11-18
• Primary Completion: 2020-08-03
• Study Completion: 2020-08-03
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-25
• Last Update Posted: 2022-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1359

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acute ischemic stroke patients	Brain CT imaging	Acute ischemic stroke patients who received intravenous (IV) thrombolysis and/or intra-arterial (IA) recanalization treatment

Primary Outcome Measures

Name	Time	Method
Death	6 months after discharge day
Recanalization rate	after 32 hrs thrombolytic treatments in MRA, CTA, or digital subtraction angiography (DSA)
asymptomatic hemorrhagic transformation rate	after 32 hrs thrombolysis in MR or CT
Modified Rankin scale scores	3 months after discharge day
Symptomatic hemorrhagic transformation rate	after 32 hrs thrombolytic treatments in MR or CT
National Institutes of Health Stroke Scale (NIHSS) scores	1 hr after IV rt-PA infusion

Trial Locations

Locations (1)

Department of Neurology, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of