UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037894 |
|---|---|
| Receipt number | R000043107 |
| Scientific Title | Hypertension, cerebral Amyloid, aGe Associated Known neuroimaging markers of cerebral small vessel disease Undertaken with stroke Registry prospective observational study |
| Date of disclosure of the study information | 2019/09/10 |
| Last modified on | 2019/09/02 15:44:07 |
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Basic information
Public title
Hypertension, cerebral Amyloid, aGe Associated Known neuroimaging markers of cerebral small vessel disease Undertaken with stroke Registry prospective observational study
Acronym
HAGAKURE study
Scientific Title
Hypertension, cerebral Amyloid, aGe Associated Known neuroimaging markers of cerebral small vessel disease Undertaken with stroke Registry prospective observational study
Scientific Title:Acronym
HAGAKURE study
Region
| Japan |
Condition
Condition
Cerebrovascular diseases
Classification by specialty
| Cardiology | Neurology | Geriatrics |
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the association between the burden of cerebral small vessel disease in patients with cerebrovascular diseases (i.e. cerebral infarction, transient ischemic attack, and cerebral hemorrhage) and their prognosis.
Basic objectives2
Others
Basic objectives -Others
Risk stratification of severity of cerebral small vessel disease for stroke recurrence, cardiovascular death, all deaths, poor functional outcome.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recurrence of stroke
Key secondary outcomes
1) Cardiovascular death
2) All-cause of death
3) Functional prognosis
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 with cerebrovascular diseases (i.e. cerebral infarction, transient ischemic attack, and cerebral hemorrhage) admitted to our division (division of neurology, department of internal medicine, Saga university hospital) from September 1, 2012 to August 31, 2016.
2. Provision of written informed consent either directly or by a suitable surrogate.
Key exclusion criteria
1. Patients who did not have any information of brain CT or MRI.
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Hideo |
| Middle name | |
| Last name | Hara |
Organization
Saga University Faculty of Medicine
Division name
Division of Neurology, Department of Internal Medicine
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga, 849-8501, Japan
TEL
0952-31-6511
hihara@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Yakushiji |
Organization
Saga University Faculty of Medicine
Division name
Division of Neurology, Department of Internal Medicine
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga, 849-8501, Japan
TEL
0952-31-6511
Homepage URL
yakushij@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the institutional review board of the Saga University Faculty of Medicine
Address
5-1-1 Nabeshima, Saga, 849-8501, Japan
Tel
0952-31-6511
medsosou1@mail.admin.saga-u.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
佐賀大学医学部附属病院（佐賀県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 10 | 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
772
Results
We enrolled 583 ischemic stroke patients (including transient ischemic attack) and 189 primary intra cerebral hemorrhage.
Results date posted
| 2019 | Year | 08 | Month | 26 | Day |
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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2012 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 15 | Day |
Date of closure to data entry
| 2019 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 11 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Patients enrolled in this study were followed up at 6 months, 1 year, and 2 year after the onset of of stroke (including transient ischemic attack).
Management information
Registered date
| 2019 | Year | 09 | Month | 02 | Day |
Last modified on
| 2019 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043107
