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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02964052
Enrollment
1359
Registered
2016-11-15
Start date
2016-11-18
Completion date
2020-08-03
Last updated
2022-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

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.

Interventions

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.

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Modified Rankin scale scores3 months after discharge day
Death6 months after discharge day
National Institutes of Health Stroke Scale (NIHSS) scores1 hr after IV rt-PA infusion
Recanalization rateafter 16 hrs thrombolytic treatments in MRA, CTA, or digital subtraction angiography (DSA)
Symptomatic hemorrhagic transformation rateafter 16 hrs thrombolytic treatments in MR or CT
asymptomatic hemorrhagic transformation rateafter 16 hrs thrombolysis in MR or CT

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026