Kanagawa Intravenous and Endvascular Treatment Registry

• Conditions: Acute Ischemic Stroke

• Registration Number: NCT05213533
• Lead Sponsor: St. Marianna University Toyoko Hospital

Brief Summary

The K-NET registry is a prospective, multicenter, observational registry study for all consecutive patients who received intravenous tPA therapy and/or endovascular treatment for acute ischemic stroke. This study is attended by 40 of the 58 Primary Stroke Centers in Kanagawa Prefecture, which is located in the Tokyo metropolitan area and has a population of 9.24 million. Patient enrollment for this study began in January 2018.

Detailed Description

Inclusion criteria for this study are all consecutive patients who meet either or both of the patients who received intravenous tPA therapy for acute ischemic stroke and intention to perform EVT for large vessel occlusion. There were no exclusion criteria. The local neurologists, neurosurgeons, and neurointerventionalists at each institution made the decision to perform EVT and intravenous tPA.

The primary outcome was good as defined by the modified Rankin Scale (mRS) of 0 to 2 at three months. We also determined a favorable outcome: mRS 0-2 or not worsening of the mRS score at three months. Secondary analyses included predicting a favorable outcome using multivariate logistic regression analysis.

Study Timeline

• Study Start: 2018-01-01
• Status Verified: 2022-01
• Study First Submitted: 2022-01-16
• Study First Submitted QC: 2022-01-16
• Study First Posted: 2022-01-28
• Last Update Submitted: 2022-01-28
• Last Update Posted: 2022-02-11
• Primary Completion: 2022-04
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

Inclusion criteria for this study are all consecutive patients who meet either or both of the patients who received intravenous tPA therapy for acute ischemic stroke and intention to perform EVT for large vessel occlusion.

Exclusion Criteria

There were no exclusion criteria. There are no upper or lower age limits for this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
modified Rankin Scale	after 3 months	The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 6. This is the most widely used outcome measure in stroke clinical trials. Standardized interviews to obtain a mRS score are recommended at 3 months following hospital discharge.; 0 The patient has no residual symptoms.; 1. The patient has no significant disability; able to carry out all pre-stroke activities.; 2. The patient has slight disability; unable to carry out all pre-stroke activities but able to look after self without daily help.; 3. The patient has moderate disability; requiring some external help but able to walk without the assistance of another individual.; 4. The patient has moderately severe disability; unable to walk or attend to bodily functions without assistance of another individual.; 5. The patient has severe disability; bedridden, incontinent, requires continuous care.; 6. The patient has expired.

Trial Locations

Locations (1)

St.Marianna University Toyoko Hospital; 🇯🇵 Kawasaki, Kanagawa, Japan