Kanagawa Intravenous and Endvascular Treatment Registry

Acute Ischemic Stroke Clinical Trial

— K-NET  

Official title:

Kanagawa Intravenous and Endovascular Treatment Registry for Acute Ischemic Stroke

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05213533
• Other study ID #: 3757
• Status: Enrolling by invitation
• Start date: January 1, 2018
• Est. completion date: October 2022

Study information

• Verified date: January 2022
• Source: St. Marianna University Toyoko Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 4000
• Est. completion date: October 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemic Stroke
• Stroke

Locations

Country	Name	City	State
Japan	St.Marianna University Toyoko Hospital	Kawasaki	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
St. Marianna University Toyoko Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	modified Rankin Scale	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.; The patient has no significant disability; able to carry out all pre-stroke activities.; The patient has slight disability; unable to carry out all pre-stroke activities but able to look after self without daily help.; The patient has moderate disability; requiring some external help but able to walk without the assistance of another individual.; The patient has moderately severe disability; unable to walk or attend to bodily functions without assistance of another individual.; The patient has severe disability; bedridden, incontinent, requires continuous care.; The patient has expired.	after 3 months