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National Cerebral and Cardiovascular Center (NCVC) Stroke Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02251665
Recruitment Status : Active, not recruiting
First Posted : September 29, 2014
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
Kazunori Toyoda, National Cerebral and Cardiovascular Center

Study Description
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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.

Condition or disease Intervention/treatment
Stroke, Acute Other: No intervention

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 Design
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Study Type : Observational
Actual Enrollment : 5374 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: National Cerebral and Cardiovascular Center (NCVC) Stroke Registry
Actual Study Start Date : October 2016
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Number of participants [ Time Frame: at entry ]
    Also assessing underlying patients' characteristics prior to index stroke/TIA

  2. National Institutes of Health Stroke Scale score [ Time Frame: at entry ]
    Also assessing neurological and cognitive states

  3. Volume of culprit infarcts/hematoma [ Time Frame: at entry ]
    ASPECTS on DWI for ischemia or hematoma volume using the ABC/2 method

  4. 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.

  5. 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)

  6. 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.

  7. Events of cardiovascular diseases including stroke/TIA [ Time Frame: 3 months ]
  8. Events of cardiovascular diseases including stroke/TIA [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Inpatients
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02251665


Locations
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Japan
National Cerebral and Cardiovascular Center
Suita, Osaka, Japan, 564-8565
Sponsors and Collaborators
National Cerebral and Cardiovascular Center
Investigators
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Principal Investigator: Kazunori Toyoda, MD, PhD Vice Director of the Hospital, National Cerebral and Cardiovascular Center
More Information
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Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kazunori Toyoda, Director and Chair, Dept. of Stroke and Cerebrovascular Diseases, National Cerebral and Cardiovascular Center
ClinicalTrials.gov Identifier: NCT02251665    
Other Study ID Numbers: NationalCardioCenter
First Posted: September 29, 2014    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020
Keywords provided by Kazunori Toyoda, National Cerebral and Cardiovascular Center:
Acute ischemic stroke
Acute intracerebral hemorrhage
Transient ischemic attack
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases