UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014542 |
|---|---|
| Receipt number | R000016915 |
| Scientific Title | Pathological diagnosis and clinical characteristics of cerebral amyloid angiopathy-related intracerebral hemorrhage |
| Date of disclosure of the study information | 2014/07/14 |
| Last modified on | 2016/07/12 12:54:55 |
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Basic information
Public title
Pathological diagnosis and clinical characteristics of cerebral amyloid angiopathy-related intracerebral hemorrhage
Acronym
Pathological diagnosis and clinical characteristics of CAA-ICH
Scientific Title
Pathological diagnosis and clinical characteristics of cerebral amyloid angiopathy-related intracerebral hemorrhage
Scientific Title:Acronym
Pathological diagnosis and clinical characteristics of CAA-ICH
Region
| Japan |
Condition
Condition
Cerebral amyloid angiopathy
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Cerebral amyloid angiopathy-related intracerebral hemorrhage (CAA-ICH) typically presents recurrent or multiple lobar hemorrhage. Pathological survey and proof of amyloid-laden blood vessels are needed to make definite diagnosis of CAA. We investigate the efficacy of biopsy and pathological diagnosis of CAA –ICH in patients with subcortical hemorrhage who undergo hematoma evacuation with craniotomy and review the clinical and radiological characteristics of pathologically proven CAA patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We will clarify clinical characteristics and efficacy of pathological diagnosis of CAA-ICH. We will establish the method of clinical diagnosis and treatment of CAA.
Key secondary outcomes
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
The patients with subcortical hemorrhage who undergo hematoma evacuation surgery and biopsy of hematoma and cerebral parenchyma for pathological diagnosis.
Written informed consent about the objects, methods, expected results and hazard of this study must be obtained from the patients.
In patients who had underwent craniotomy and biopsy for pathological survey before an application of this study, surgical consent form and informed consent about biopsy for pathological survey documented in medical records can be regarded as a written informed consent for this study.
Key exclusion criteria
Cases with subcortical hemorrhages which are derived from causes other than CAA.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takao Hashimoto |
Organization
Aizawa Hospital
Division name
Department of Neurology
Zip code
Address
2-5-1 Honjo, Matsumoto 390-8510, Japan
TEL
0263-33-8600
sinke-dr@ai-hosp.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadashi Doden |
Organization
Aizawa Hospital
Division name
Department of Neurology
Zip code
Address
2-5-1 Honjo, Matsumoto 390-8510, Japan
TEL
0263-33-8600
Homepage URL
aidr214@ai-hosp.or.jp
Sponsor or person
Institute
Aizawa Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
相澤病院（長野県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2014 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We investigate the efficacy of biopsy and pathological diagnosis of CAA related ICH in patients with subcortical hemorrhage who undergo hematoma evacuation with craniotomy and review the clinical and radiological characteristics of pathologically proven CAA patients.
Management information
Registered date
| 2014 | Year | 07 | Month | 12 | Day |
Last modified on
| 2016 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016915
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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