Kanagawa Intravenous and Endvascular Treatment Registry (K-NET)

January 28, 2022 updated by: Toshihiro Ueda, MD, St. Marianna University Toyoko Hospital

Kanagawa Intravenous and Endovascular Treatment Registry for Acute Ischemic Stroke

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.

Study Overview

Status

Enrolling by invitation

Conditions

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 Type

Observational

Enrollment (Anticipated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 211-0063
        • St.Marianna University Toyoko Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Residents of Kanagawa prefecture in Japan

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
modified Rankin Scale
Time Frame: 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.
after 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Marianna University Toyoko Hospital

Investigators

  • Principal Investigator: Toshihiro Ueda, MD, St. Marianna University Toyoko Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

January 16, 2022

First Submitted That Met QC Criteria

January 16, 2022

First Posted (Actual)

January 28, 2022

Study Record Updates

Last Update Posted (Actual)

February 11, 2022

Last Update Submitted That Met QC Criteria

January 28, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3757

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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