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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000015489
Receipt No. R000018000
Scientific Title Comparative study for detectability of intracranial microvascular lesions among DSA, CT-DSA and MR-DSA
Date of disclosure of the study information 2014/10/21
Last modified on 2014/10/21

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Basic information
Public title Comparative study for detectability of intracranial microvascular lesions among DSA, CT-DSA and MR-DSA
Acronym Comparative study for detectability of intracranial microvascular lesions among DSA, CT-DSA and MR-DSA
Scientific Title Comparative study for detectability of intracranial microvascular lesions among DSA, CT-DSA and MR-DSA
Scientific Title:Acronym Comparative study for detectability of intracranial microvascular lesions among DSA, CT-DSA and MR-DSA
Region
Japan

Condition
Condition dural arterio-venous fistula, intracranial arterio-venous malformation, intracranial hemorrahage, brain edema, subarachnoid hemorrhage
Classification by specialty
Radiology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm efficasy of CT-DSA and MR-DSA in the initial diagnosis of intracranial microvascular lesions including artero-venous shunts
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes detection of intracranial vascular lesions
Key secondary outcomes quality of imaging, clinical status, treatment

Base
Study type

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 CT-DSA, MR-DSA, DSA
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
90 years-old >=
Gender Male and Female
Key inclusion criteria 1) or 2)
1) patients aged 20 to 75 with subcortical hemorrhage, subuarachnoid hemorrhage without aneurysms and trauma and vascular edema without mass lesions
2) patients over 20 without or with mild symptoms whose brain MRI suggests underlined vascular lesions
Key exclusion criteria 1) renal function disturbance
2) pregnant patient
3) iodine allergy, asthma
4) evident vascular lesions such as cerebral aneurysms, AVM, brain tumor , angioma or Moyamoya disease detected in MRI
5) bleeding tendency
6) brain trauma, post intracranial surgery within 48 hours
7) acute dural sinus thrombosis, amyloid angiopathy
8) uncontrolled hypertension, malignancy, infection
9) physician's judgement
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takenori Akiyama
Organization Keio University, School of Medicine
Division name Department of Neurosurgery
Zip code
Address 35 Shinanomachi, Shinjukuku, Tokyo, Japan
TEL 03-3353-1211
Email takiyama-jsccn@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takenori Akiyama
Organization Keio University, School of Medicine
Division name Department of Neurosurgery
Zip code
Address 35 Shinanomachi, Shinjukuku, Tokyo, Japan
TEL 03-3353-1211
Homepage URL
Email takiyama-jsccn@umin.ac.jp

Sponsor
Institute Department of Neurosurgery, Keio University, School of Medicine
Institute
Department

Funding Source
Organization Department of Neurosurgery, Keio University, School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Mihara memorial hospital
Saiseikai Yokohama East Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 20140208
Org. issuing International ID_1 Keio University school of medicine, an ethical committee
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2014 Year 10 Month 21 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 Preinitiation
Date of protocol fixation
2014 Year 10 Month 15 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 10 Month 21 Day
Last modified on
2014 Year 10 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018000

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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