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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031913
Receipt No. R000036442
Scientific Title A prospective observational registry of patients with acute ischemic stoke or transient ischemic attack in the Department of Neurology, Tokyo Women's Medical University Hospital
Date of disclosure of the study information 2018/03/27
Last modified on 2020/10/26

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Basic information
Public title A prospective observational registry of patients with acute ischemic stoke or transient ischemic attack in the Department of Neurology, Tokyo Women's Medical University Hospital
Acronym TWMU Stroke Registry
Scientific Title A prospective observational registry of patients with acute ischemic stoke or transient ischemic attack in the Department of Neurology, Tokyo Women's Medical University Hospital
Scientific Title:Acronym TWMU Stroke Registry
Region
Japan

Condition
Condition Acute ischemic stroke, transient ischemic attack
Classification by specialty
Medicine in general Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To describe clinical characteristics and prognosis of acute ischemic stroke or transient ischemic attack.
Basic objectives2 Others
Basic objectives -Others This is an observational study to determine predictive factors for poor prognosis in patients with acute ischemic stroke or transient ischemic attack.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Major cardiovascular event
Key secondary outcomes Neurological/physical symptom, comorbidities, functional outcomes, blood, urine, CSF, CT, MRI, vessel imagings, perfusion imagings, ultrasound (carotid, transcranial, cardiac, lower extrimities), endothelial function, ECG monitoring

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with acute ischemic stroke or transient ischemic attack within one week of onset
Key exclusion criteria Patients who did not consent to participate in this study
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Kazuo
Middle name
Last name Kitagawa
Organization Tokyo Women's Medical University
Division name Department of Neurology
Zip code 1628666
Address 8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL 0333538111
Email kitagawa.kazuo@twmu.ac.jp

Public contact
Name of contact person
1st name Takao
Middle name
Last name Hoshino
Organization Tokyo Women's Medical University
Division name Department of Neurology
Zip code 1628666
Address 8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL 0333538111
Homepage URL
Email hoshino.takao@twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokyo Women's Medical University IRB
Address 8-1, Kawada-cho, Shinjuku-ku, Tokyo
Tel 03-3353-8112
Email Krinri.bm@twmu.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 27 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2013 Year 12 Month 01 Day
Date of IRB
2013 Year 12 Month 01 Day
Anticipated trial start date
2013 Year 12 Month 01 Day
Last follow-up date
2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We use a standardized case report form and abstract a number of demographic and clinical variables including date of the event, past medical history, risk factors , prior medications, physiological examination findings, and neurological symptoms. We also document the results of all diagnostic tests and details of treatment performed during the hospitalization and at discharge. Stroke-related disability is assessed using the modified Rankin Scale score at the 3-month follow-up. When the patients cannot attend the follow-up appointment, we contact their family members or the staff of the rehabilitation center or nursing home over the telephone. We also collect data on the occurence of major cardiovascular events at 12- and 36-month.

Management information
Registered date
2018 Year 03 Month 27 Day
Last modified on
2020 Year 10 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036442

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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