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NCT Number: NCT02964052

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

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Neurology, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brain CT imaging

Other

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.

Primary outcomes

  1. Modified Rankin scale scores

    Time frame: 3 months after discharge day

  2. Death

    Time frame: 6 months after discharge day

  3. National Institutes of Health Stroke Scale (NIHSS) scores

    Time frame: 1 hr after IV rt-PA infusion

  4. Recanalization rate

    Time frame: after 16 hrs thrombolytic treatments in MRA, CTA, or digital subtraction angiography (DSA)

  5. Recanalization rate

    Time frame: after 24 hrs thrombolytic treatments in MRA, CTA, or digital subtraction angiography (DSA)

  6. Recanalization rate

    Time frame: after 32 hrs thrombolytic treatments in MRA, CTA, or digital subtraction angiography (DSA)

  7. Symptomatic hemorrhagic transformation rate

    Time frame: after 16 hrs thrombolytic treatments in MR or CT

  8. Symptomatic hemorrhagic transformation rate

    Time frame: after 24 hrs thrombolytic treatments in MR or CT

  9. Symptomatic hemorrhagic transformation rate

    Time frame: after 32 hrs thrombolytic treatments in MR or CT

  10. asymptomatic hemorrhagic transformation rate

    Time frame: after 16 hrs thrombolysis in MR or CT

  11. asymptomatic hemorrhagic transformation rate

    Time frame: after 24 hrs thrombolysis in MR or CT

  12. asymptomatic hemorrhagic transformation rate

    Time frame: after 32 hrs thrombolysis in MR or CT

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Nov 15, 2016
Registry last updated
Dec 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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