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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043107


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name