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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

NCT ID: NCT02964052

Last Updated: 2022-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1359 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-18

Study Completion Date

2020-08-03

Brief Summary

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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

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Conditions

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Ischemic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Acute ischemic stroke patients

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

Brain CT imaging

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Neurology, Yonsei University College of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Kim HJ, Park MS, Yoo J, Kim YD, Park H, Kim BM, Bang OY, Kim HC, Han E, Kim DJ, Heo J, Choi JK, Lee KY, Lee HS, Shin DH, Choi HY, Sohn SI, Hong JH, Lee JY, Baek JH, Kim GS, Seo WK, Chung JW, Kim SH, Han SW, Park JH, Kim J, Jung YH, Cho HJ, Ahn SH, Lee SI, Seo KD, Chang Y, Song TJ, Nam HS; SECRET Study Investigators. Association between CHADS2, CHA2DS2-VASc, ATRIA, and Essen Stroke Risk Scores and Unsuccessful Recanalization after Endovascular Thrombectomy in Acute Ischemic Stroke Patients. J Clin Med. 2022 Jan 5;11(1):274. doi: 10.3390/jcm11010274.

Reference Type DERIVED
PMID: 35012015 (View on PubMed)

Other Identifiers

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4-2015-1196

Identifier Type: -

Identifier Source: org_study_id