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

Ischemic Stroke Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02964052
• Other study ID #: 4-2015-1196
• Status: Completed
• Start date: November 18, 2016
• Est. completion date: August 3, 2020

Study information

• Verified date: December 2022
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1359
• Est. completion date: August 3, 2020
• Est. primary completion date: August 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Other:
• Brain CT imaging
Investigators will analyzed the CT image that was performed in patients with hyperacute stroke. The CT protocol includes CT thrombus, collateral, core images. Investigators also obtain detailed history and laboratory and imaging result for comorbidity. The comorbidity index protocol is based on the Charlson comorbidity index.

Locations

Country	Name	City	State
Korea, Republic of	Department of Neurology, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Rankin scale scores		3 months after discharge day
Primary	Death		6 months after discharge day
Primary	National Institutes of Health Stroke Scale (NIHSS) scores		1 hr after IV rt-PA infusion
Primary	Recanalization rate		after 16 hrs thrombolytic treatments in MRA, CTA, or digital subtraction angiography (DSA)
Primary	Recanalization rate		after 24 hrs thrombolytic treatments in MRA, CTA, or digital subtraction angiography (DSA)
Primary	Recanalization rate		after 32 hrs thrombolytic treatments in MRA, CTA, or digital subtraction angiography (DSA)
Primary	Symptomatic hemorrhagic transformation rate		after 16 hrs thrombolytic treatments in MR or CT
Primary	Symptomatic hemorrhagic transformation rate		after 24 hrs thrombolytic treatments in MR or CT
Primary	Symptomatic hemorrhagic transformation rate		after 32 hrs thrombolytic treatments in MR or CT
Primary	asymptomatic hemorrhagic transformation rate		after 16 hrs thrombolysis in MR or CT
Primary	asymptomatic hemorrhagic transformation rate		after 24 hrs thrombolysis in MR or CT
Primary	asymptomatic hemorrhagic transformation rate		after 32 hrs thrombolysis in MR or CT