UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015489 |
|---|---|
| Receipt number | 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 11:55:10 |
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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
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
takiyama-jsccn@umin.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, Keio University, School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018000
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
