National Cerebral and Cardiovascular Center (NCVC) Stroke Registry

November 7, 2023 updated by: Kazunori Toyoda, National Cerebral and Cardiovascular Center, Japan
A single-center registry of patients with acute ischemic stroke, intracerebral hemorrhage, and transient ischemic attack (TIA) who are emergently managed in the stroke care unit in the National Cerebral and Cardiovascular Center (NCVC) to determine change in underlying characteristics, stroke features and severity, process for diagnosis and acute treatment, and long-term outcomes of stroke/TIA patients over the years.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a single-center registry of consecutive patients with acute ischemic stroke, intracerebral hemorrhage, and transient ischemic attack (TIA) who are emergently managed in the stroke care unit in the National Cerebral and Cardiovascular Center, a flagship stroke center in Japan.

Neurological emergencies other than stroke/TIA and subclinical cerebrobvascular inpatients are also enrolled.

Data are collected and analyzed to determine change in underlying characteristics, stroke features and severity, process for diagnosis and acute treatment, and long-term outcomes of stroke/TIA patients over the years.

The National Cerebral and Cardiovascular Center was founded in 1977 in Suita, Osaka, in order to provide the public with the most advanced treatment for cardiovascular and cerebrovascular diseases and to conduct the highest level of basic as well as applied research on the cardiovascular and cerebrovascular systems.

Study Type

Observational

Enrollment (Actual)

5374

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
    • Osaka
      • Suita, Osaka, Japan, 564-8565
        • National Cerebral and Cardiovascular Center

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

Sampling Method

Non-Probability Sample

Study Population

Inpatients

Description

Inclusion Criteria:

  1. A patient with acute ischemic stroke, intracerebral hemorrhage, and transient ischemic attack who are emergently managed in the stroke care unit or stroke units in the National Cerebral and Cardiovascular Center (NCVC)
  2. Consent to participate in the registration by a patient or relatives obtained using an opt-out approach by the demonstrating contents of the registration on the hospital bulletin board

Exclusion Criteria:

1) Patients considered by the investigator to be unsuitable for participating in this registry

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Acute ischemic stroke, acute ICH, TIA
Consecutive patients with acute ischemic stroke, intracerebral hemorrhage, and transient ischemic attack who are emergently managed in the stroke care unit or stroke units in the National Cerebral and Cardiovascular Center
Other: No intervention
a single-center prospective observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The modified Rankin Scale (mRS), a measure of disability
Time Frame: 3 monhts
mRS scores range from 0 (no symptoms at all) to 6 (death)
3 monhts

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants
Time Frame: at entry
Also assessing underlying patients' characteristics prior to index stroke/TIA
at entry
National Institutes of Health Stroke Scale score
Time Frame: at entry
Also assessing neurological and cognitive states
at entry
Volume of culprit infarcts/hematoma
Time Frame: at entry
ASPECTS on DWI for ischemia or hematoma volume using the ABC/2 method
at entry
The modified Rankin Scale (mRS), a measure of disability
Time Frame: around 3 weeks
mRS scores range from 0 (no symptoms at all) to 6 (death). Participants will be followed at hospital discharge, an expected average of 3 weeks.
around 3 weeks
The modified Rankin Scale (mRS), a measure of disability
Time Frame: 1 year
mRS scores range from 0 (no symptoms at all) to 6 (death)
1 year
Events of cardiovascular diseases including stroke/TIA
Time Frame: around 3 weeks
Participants will be followed at hospital discharge, an expected average of 3 weeks.
around 3 weeks
Events of cardiovascular diseases including stroke/TIA
Time Frame: 3 months
3 months
Events of cardiovascular diseases including stroke/TIA
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

National Cerebral and Cardiovascular Center, Japan

Investigators

  • Principal Investigator: Kazunori Toyoda, MD, PhD, Vice Director of the Hospital, National Cerebral and Cardiovascular Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

October 1, 2016

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

September 23, 2014

First Submitted That Met QC Criteria

September 25, 2014

First Posted (Estimated)

September 29, 2014

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NationalCardioCenter

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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