Skip to main content
Clinical Trials/NCT02964052
NCT02964052
Completed
Not Applicable

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

Yonsei University1 site in 1 country1,359 target enrollmentNovember 18, 2016
ConditionsIschemic Stroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ischemic Stroke
Sponsor
Yonsei University
Enrollment
1359
Locations
1
Primary Endpoint
Death
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 18, 2016
End Date
August 3, 2020
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Death

Time Frame: 6 months after discharge day

Recanalization rate

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

asymptomatic hemorrhagic transformation rate

Time Frame: after 32 hrs thrombolysis in MR or CT

Modified Rankin scale scores

Time Frame: 3 months after discharge day

Symptomatic hemorrhagic transformation rate

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

National Institutes of Health Stroke Scale (NIHSS) scores

Time Frame: 1 hr after IV rt-PA infusion

Study Sites (1)

Loading locations...

Similar Trials