UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057579 |
|---|---|
| Receipt number | R000065790 |
| Scientific Title | Observational Investigation into the Pathophysiological Mechanisms in Acute and Chronic Stroke Patients(The Hirosaki Stroke Registry Ver.2:HSR2) |
| Date of disclosure of the study information | 2025/04/11 |
| Last modified on | 2025/04/10 17:27:41 |
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Basic information
Public title
The Hirosaki Stroke Registry Ver.2(HSR2)
Acronym
The Hirosaki Stroke Registry Ver.2(HSR2)
Scientific Title
Observational Investigation into the Pathophysiological Mechanisms in Acute and Chronic Stroke Patients(The Hirosaki Stroke Registry Ver.2:HSR2)
Scientific Title:Acronym
The Hirosaki Stroke Registry Ver.2(HSR2)
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Medicine in general | Cardiology | Neurology |
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the pathophysiology and prognosis of stroke patients, improve stroke care, and contribute to better survival, functional outcomes, and prevention.
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Functional outcomes and severity assessed based on clinical findings at onset, blood test data, medication status, acute-phase treatment, stroke subtype, and patient background.
Key secondary outcomes
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
1. Patients who were admitted to our hospital during the study period with symptomatic stroke (including TIA) or suspected stroke, within 60 days of onset.
2. The written consent can be obtained from the patient or their representative.
3. The age at the time of obtaining consent in writing must be 20 years or older.
Key exclusion criteria
1.The cause is determined to be traumatic.
2.Patients who were judged not to have clearly suffered a stroke.
3.Patients who are deemed ineligible by a physician.
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Joji |
| Middle name | |
| Last name | Hagii |
Organization
Hirosaki Strok and Rehabilitaion Center
Division name
Internal Medicine Department
Zip code
036-8104
Address
1-2-1,Oogi-machi,Hirosaki-shi,Aomori,036-8104,JAPAN
TEL
0172-28-8220
j_hagii@reimeikyou.jp
Public contact
Name of contact person
| 1st name | Joji |
| Middle name | |
| Last name | Hagii |
Organization
Hirosaki Strok and Rehabilitaion Center
Division name
Internal Medicine Department
Zip code
036-8104
Address
1-2-1,Oogi-machi,Hirosaki-shi,Aomori,036-8104,JAPAN
TEL
0172-28-8220
Homepage URL
j_hagii@reimeikyou.jp
Sponsor or person
Institute
Hirosaki Strok and Rehabilitaion Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hirosaki Strok and Rehabilitaion Center Ethics review committee
Address
1-2-1,Oogi-machi,Hirosaki-shi,Aomori,036-8104,JAPAN
Tel
0172-28-8220
info@reimeikyou.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
弘前脳卒中・リハビリテーションセンター（青森県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 11 | 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
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1.Research Design: Non-interventional, prospective, registry-based observational study
2.Recruitment Method: Patients who are hospitalized for a stroke at our facility after April 2025, meet the selection criteria, and have provided written informed consent.
3.Survey Method: Data will be collected using the medical records from the time of admission due to stroke until discharge.
Management information
Registered date
| 2025 | Year | 04 | Month | 10 | Day |
Last modified on
| 2025 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065790
