UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031913 |
|---|---|
| Receipt number | 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 | 2022/04/02 19:10:50 |
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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
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
hoshino.takao@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
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
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
Partially published
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
| 2022 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.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 |
