National Cerebral and Cardiovascular Center (NCVC) Stroke Registry

Active, not recruiting

• Conditions: Stroke, Acute
• Interventions: Other: No intervention

• Registration Number: NCT02251665
• Lead Sponsor: National Cerebral and Cardiovascular Center, Japan

Brief Summary

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.

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 Timeline

• Study First Submitted: 2014-09-23
• Study First Submitted QC: 2014-09-25
• Study First Posted: 2014-09-29
• Study Start: 2016-10
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-09
• Primary Completion: 2027-03
• Study Completion: 2028-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 5374

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acute ischemic stroke, acute ICH, TIA	No intervention	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

Primary Outcome Measures

Name	Time	Method
The modified Rankin Scale (mRS), a measure of disability	3 monhts	mRS scores range from 0 (no symptoms at all) to 6 (death)

Secondary Outcome Measures

Name	Time	Method
Number of participants	at entry	Also assessing underlying patients' characteristics prior to index stroke/TIA
The modified Rankin Scale (mRS), a measure of disability	1 year	mRS scores range from 0 (no symptoms at all) to 6 (death)
National Institutes of Health Stroke Scale score	at entry	Also assessing neurological and cognitive states
Volume of culprit infarcts/hematoma	at entry	ASPECTS on DWI for ischemia or hematoma volume using the ABC/2 method
Events of cardiovascular diseases including stroke/TIA	1 year

Trial Locations

Locations (1)

National Cerebral and Cardiovascular Center; 🇯🇵 Suita, Osaka, Japan