UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013555 |
|---|---|
| Receipt number | R000015838 |
| Scientific Title | Clinical survey of patients with cerebrovascular diseases (MBs study) |
| Date of disclosure of the study information | 2014/04/01 |
| Last modified on | 2015/09/01 22:29:36 |
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Basic information
Public title
Clinical survey of patients with cerebrovascular diseases (MBs study)
Acronym
Clinical survey of patients with cerebrovascular diseases (MBs study)
Scientific Title
Clinical survey of patients with cerebrovascular diseases (MBs study)
Scientific Title:Acronym
Clinical survey of patients with cerebrovascular diseases (MBs study)
Region
| Japan |
Condition
Condition
Cerebrovascular diseases
Classification by specialty
| Medicine in general | Neurology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To survey the clinical characteristics of patients with cerebrovascular diseases
Basic objectives2
Others
Basic objectives -Others
To clarify the clinical characteristics of patients with cerebrovascular diseases and whether various risk factors including renal impairment could be associated with their outcomes, such as discharge destinations and long-term mortalities.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
functional outcome, discharge destinations, and long-term mortality
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
Between April 2007 and March 2013, patients with acute ischemic stroke who were admitted to our hospital within 24 hours of stroke onset.
Key exclusion criteria
Patients with recurrence of stroke were excluded.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Saji |
Organization
Kawasaki Medical School
Division name
Department of Stroke Medicine
Zip code
Address
577 Matsushima, Kurashiki, Okayama
TEL
086-462-1111
sajink@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Saji |
Organization
Kawasaki Medical School
Division name
Department of Stroke Medicine
Zip code
Address
577 Matsushima, Kurashiki, Okayama
TEL
086-462-1111
Homepage URL
sajink@nifty.com
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
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
川崎医科大学（岡山県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.strokejournal.org/article/S1052-3057(15)00396-1/fulltext
Publication of results
Published
Result
URL related to results and publications
http://www.strokejournal.org/article/S1052-3057(15)00396-1/fulltext
Number of participants that the trial has enrolled
Results
International Stroke Conference 2014
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
| 2013 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 28 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 28 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 29 | Day |
Date analysis concluded
| 2014 | Year | 04 | Month | 08 | Day |
Other
Other related information
Background: Cerebral small-vessel disease (SVD) is associated with renal dysfunction such as chronic kidney disease. Although cerebral microbleeds (CMBs) are common in patients with acute lacunar infarcts (ALI), the association between renal dysfunction and CMBs in such patients remains unclear.
Methods: Between April 2007 and March 2013, we evaluated consecutive first-ever ALI patients, who were admitted to our hospital within 24 hours of stroke onset. CMBs were defined as focal areas of signal loss in brain parenchyma less than 5 mm on T2* weighted gradient-echo imaging. Renal dysfunction was defined as an estimated glomerular filtration rate less than 60 mL/minute/1.73 m2 on admission. Correlations between renal dysfunction and the presence (model 1) and location of CMBs (model 2; any deep or infratentorial CMBs) were determined by multivariable logistic regression analyses.
Results: Among 152 patients (33.6% men; mean age, 67.6 years), 53 had CMBs. Patients with CMBs were older (69.9 versus 66.3 years, P = .03) and had a higher frequency of white matter hyperintensity (WMH; 62.3% versus 25.3%, P < .001), silent lacunar infarcts (SLI; 75.5% versus 43.3%, P < .001), and renal dysfunction (41.5% versus 22.2%, P = .015) than those without CMBs. On multivariable analyses, renal dysfunction (odds ratio, 95% confidence interval; model 1: 2.38, 1.02-5.66; model 2: 2.78, 1.16-6.81), WMH (3.87, 1.76-8.80; 3.72, 1.64-8.71), SLI (3.85, 1.71-9.14; 4.20, 1.77-10.8), and diabetes mellitus (.26, .09-.63; .24, .08-.63) were independently associated with CMBs.
Conclusions: In patients with ALI, renal dysfunction was positively associated with CMBs independent of cerebral SVD.
Management information
Registered date
| 2014 | Year | 03 | Month | 29 | Day |
Last modified on
| 2015 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015838
