UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002204 |
|---|---|
| Receipt number | R000002709 |
| Scientific Title | Biochemical parameter seeking for the diagnosis of atherothrombotic brain infarction. |
| Date of disclosure of the study information | 2009/07/28 |
| Last modified on | 2011/01/17 09:46:56 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Biochemical parameter seeking for the diagnosis of atherothrombotic brain infarction.
Acronym
biochemical diagnosis of atherothombotic stroke
Scientific Title
Biochemical parameter seeking for the diagnosis of atherothrombotic brain infarction.
Scientific Title:Acronym
biochemical diagnosis of atherothombotic stroke
Region
| Japan |
Condition
Condition
brain ischemic stroke
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
seeking biochemical parameters that changes specifically on the onset of aterothrombotic brain infarction and confirmation of usefulness as a differentiating marker.
Basic objectives2
Others
Basic objectives -Others
seeding useful biochemical parameters for the diagnosis
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
measures of biochemical parameter that were routinely measured in clinic setting.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
all of patients with a new brain ischemic stroke
Key exclusion criteria
patients with animia and liver disease
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masafumi Kakei |
Organization
Jichi Medical University, Saitama Medical Center
Division name
First Department of Internal Medicine
Zip code
Address
1-847 Amanuma Omiya, Saitama, Japan
TEL
048-647-2111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masafumi Kakei |
Organization
Saitama Medical Center
Division name
First Department of Internal Medicine
Zip code
Address
1-847 Amanuma Omiya, Saitama, Japan
TEL
048-647-2111
Homepage URL
Sponsor or person
Institute
Jichi Medical University, Saitama Medical Center
Institute
Department
Personal name
Funding Source
Organization
Jichi Medical University, Saitama Medical Center
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 07 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
ratio of glycated albumin/glycohemoglobin is increased on admission for the patients with atherothrombotic brain infarction.
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
| 2006 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 01 | Month | 01 | Day |
Other
Other related information
Measures of the ratio of glycated albumin/glycohemoblobin is useful for the diagnosis of atherothrombotic stroke. Other biochemical paramters did not change among the strokes: atherothrombotic, cardioembolic and lacunar brain infarctions.
Management information
Registered date
| 2009 | Year | 07 | Month | 15 | Day |
Last modified on
| 2011 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002709
