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

December 25, 2022 updated by: Yonsei University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1359

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Department of Neurology, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Acute ischemic stroke patients who received intravenous (IV) thrombolysis and/or intra-arterial (IA) recanalization treatment

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Acute ischemic stroke patients
Acute ischemic stroke patients who received intravenous (IV) thrombolysis and/or intra-arterial (IA) recanalization treatment
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2016

Primary Completion (Actual)

August 3, 2020

Study Completion (Actual)

August 3, 2020

Study Registration Dates

First Submitted

November 7, 2016

First Submitted That Met QC Criteria

November 10, 2016

First Posted (Estimate)

November 15, 2016

Study Record Updates

Last Update Posted (Estimate)

December 28, 2022

Last Update Submitted That Met QC Criteria

December 25, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2015-1196

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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