UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013767 |
|---|---|
| Receipt number | R000016068 |
| Scientific Title | Clinical survey of patients with cerebrovascular diseases (CKD study) |
| Date of disclosure of the study information | 2014/04/20 |
| Last modified on | 2014/09/29 09:45:22 |
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Basic information
Public title
Clinical survey of patients with cerebrovascular diseases (CKD study)
Acronym
Clinical survey of patients with cerebrovascular diseases (CKD study)
Scientific Title
Clinical survey of patients with cerebrovascular diseases (CKD study)
Scientific Title:Acronym
Clinical survey of patients with cerebrovascular diseases (CKD 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 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.
Basic objectives2
Others
Basic objectives -Others
To survey the clinical characteristics of patients with cerebrovascular diseases
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To survey the clinical characteristics of patients with cerebrovascular diseases
Key secondary outcomes
Association between cerebral small vessel disease and chronic kidney disease
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
150
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, Japan
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, Japan
TEL
086-462-1111
Homepage URL
sajink@nifty.com
Sponsor or person
Institute
Department of Stroke Medicine,
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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 | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.karger.com/Article/FullText/365565
Number of participants that the trial has enrolled
Results
European 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 | 31 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 04 | Month | 30 | Day |
Other
Other related information
Background: Chronic kidney disease (CKD) predicts cardiovascular events and mortality. However, such association in acute lacunar stroke patients is not yet clarified. The aim of this study was to clarify whether CKD can independently predict cardiovascular events and mortality in acute lacunar stroke patients.
Methods: Between April 2007 and March 2013, we enrolled consecutive patients with first-ever acute lacunar infarcts who were admitted to our hospital within 24 hours after stroke onset. Lacunar infarcts were defined as <15 mm in diameter detected on initial diffusion-weighted imaging scans. CKD was defined as estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 on admission. We divided patients into two groups according to the presence or absence of CKD to compare their clinical characteristics. Event-free survival analysis was done using Kaplan-Meier plots, log-rank test, and Cox proportional-hazards model controlling for known vascular risk factors.
Results: A total of 152 patients were enrolled and 44 (29%) had CKD. The eGFR on admission were lower in patients with cerebral small vessel disease (SVD) such as microbleeds (MBs) and white matter disease (WMD) than in those without. A Kaplan-Meier curve analysis showed that patients with CKD had less favorable survival free of cardiovascular events and all-cause mortality than those without (log-rank test, P <0.001). The multivariate Cox proportional-hazards model revealed that CKD was the independent predictor of cardiovascular events and all-cause mortality after adjusting for age, sex, and the presence of cerebral SVD.
Conclusion: CKD should independently predict cardiovascular events and mortality in acute lacunar stroke patients.
Management information
Registered date
| 2014 | Year | 04 | Month | 20 | Day |
Last modified on
| 2014 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016068
