UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011341
Receipt number R000013287
Scientific Title A prospective observational study on the prognosis of intracranial arterial stenotic disease
Date of disclosure of the study information 2013/08/01
Last modified on 2015/08/14 15:06:06

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Basic information

Public title

A prospective observational study on the prognosis of intracranial arterial stenotic disease

Acronym

intracranial artery Stenosis after a NAtural course in Kyoto arEa
(iSNAKE)

Scientific Title

A prospective observational study on the prognosis of intracranial arterial stenotic disease

Scientific Title:Acronym

intracranial artery Stenosis after a NAtural course in Kyoto arEa
(iSNAKE)

Region

Japan


Condition

Condition

intracranial arterial stenosis

Classification by specialty

Neurology Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Consider the progression of the disease, the incidence of cardiovascular events, and its influencing factors exploratory on the basis of the natural course and the treatment outcome (medical treatments and endovascular treatments) of patients with symptomatic or asymptomatic intracranial arterial stenosis.

Basic objectives2

Others

Basic objectives -Others

none

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

1. 3-year incidence of progression or regression of the intracranial stenotic region
2. Occurrence of ischemic stroke in a 3-year follow-up

Key secondary outcomes

1. Occurrence of cardiovascular events (stroke, myocardial infarction, other cardiovascular events, and vasucular death) in a 3-year follow-up
2. Occurrence of all bleeding events in a 3-year follow-up
3. Occurrence of all-causes deaths in a 3-year follow-up
4. Analysis of risk factors for progression of stenotic region
5. Analysis of risk factors for stroke and cardiovascular events
6. Occurrence of development of new stenotic lesion and analysis of its risk factors


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with intracranial atherosclerotic stenotic lesions (%DS>=50%) in the intracranial main arteries confirmed by MR angiographic findings.
The target vascular lesions are as follows.
1. Internal carotid artery
2. Middle cerebral artery
3. Anterior cerebral artery
4. Posterior cerebral artery
5. Intracranial vertebral artery
6. Basilar artery

Key exclusion criteria

Case of internal medicine treatments
1. Patients with cardiogenic brain embolism
2. Whom scheduled for reconstructive surgery or endovascular treatment
3. Patients with non-atherosclerotic stenosis (artery dissection, moyamoya disease)
4. Whom considered to be difficult to follow up due to serious complications, such as brain tumor
5. Who are scheduled to remove and will be difficult to follow up
6. Who did not consent

Case of endovascular treatments
1. Patients with cardiogenic brain embolism
2. Patients with non-atherosclerotic stenosis (artery dissection, moyamoya disease)
3. Whom considered to be difficult to follow up due to serious complications, such as brain tumor
4. Who are scheduled to remove and will be difficult to follow up
5. Who did not consent

Target sample size

300


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tetsuya Tsukahara

Organization

National Hospital Organization, Kyoto Medical Center

Division name

Department of Neurosurgery

Zip code


Address

1-1Mukaihata-cho,Fukakusa,Fushimi-ku,Kyoto 612-8555 Japan

TEL

075-641-9173

Email

ttsukaha@kyotolan.hosp.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tetsuya Tsukahara

Organization

National Hospital Organization, Kyoto

Division name

Department of Neurosurgery

Zip code


Address

1-1Mukaihata-cho,Fukakusa,Fushimi-ku,Kyoto 612-8555 Japan

TEL

075-641-9173

Homepage URL


Email

ttsukaha@kyotolan.hosp.go.jp


Sponsor or person

Institute

National Hospital Organization, Kyoto
Medical Center

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

None


Other related organizations

Co-sponsor

1. Japanense Red Cross Kyoto Daini Hospital
2. Nantan General Hospital
3. National Hospital Organization, Maizuru Medical Center

Name of secondary funder(s)

None


IRB Contact (For public release)

Organization


Address


Tel


Email



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

国立病院機構京都医療センター(京都府)
京都第二赤十字病院(京都府)
公立南丹病院(京都府)
国立病院機構舞鶴医療センター(京都府)


Other administrative information

Date of disclosure of the study information

2013 Year 08 Month 01 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

2012 Year 10 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 10 Month 01 Day

Last follow-up date


Date of closure to data entry

2014 Year 09 Month 30 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information

prospective cohort study (one arm)


Management information

Registered date

2013 Year 08 Month 01 Day

Last modified on

2015 Year 08 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013287


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name