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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011341
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Institute National Hospital Organization, Kyoto
Medical Center
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013287


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