UMIN-CTR Clinical Trial

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000037894
Receipt No. 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 (Ver. 1)

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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
Email 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
Email yakushij@cc.saga-u.ac.jp

Sponsor
Institute Saga University Faculty of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043107