UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023239 |
|---|---|
| Receipt number | R000026779 |
| Scientific Title | Clinical survey to clarify the association between arterial stiffness and cerebrovascular diseases |
| Date of disclosure of the study information | 2016/07/20 |
| Last modified on | 2017/01/11 09:57:08 |
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Basic information
Public title
Clinical survey to clarify the association between arterial stiffness and cerebrovascular diseases
Acronym
Clinical survey to clarify the association between arterial stiffness and cerebrovascular diseases
Scientific Title
Clinical survey to clarify the association between arterial stiffness and cerebrovascular diseases
Scientific Title:Acronym
Clinical survey to clarify the association between arterial stiffness and cerebrovascular diseases
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 arterial stiffness could be associated with their outcomes, such as recurrent stroke 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
All-cause mortality, recurrent stroke, and cardiovascular diseases
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 October 2003 and March 2010, we enrolled consecutive patients presenting with clinical lacunar stroke syndrome who were admitted to the Department of Neurology, Hyogo Brain and Heart Center at Himeji (HBHC) within 48 hours after the 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
Hyogo Brain and Heart Center at Himeji (National Center for Geriatrics and Gerontology)
Division name
Department of Neurology (Center for Comprehensive Care and Research on Memory Disorders)
Zip code
Address
520, Saisho-ko, Himeji, Hyogo (7-430, Morioka, Obu, Aichi)
TEL
0562-46-2311
sajink@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Saji |
Organization
Hyogo Brain and Heart Center at Himeji (National Center for Geriatrics and Gerontology)
Division name
Department of Neurology (Center for Comprehensive Care and Research on Memory Disorders)
Zip code
Address
520, Saisho-ko, Himeji, Hyogo (7-430, Morioka, Obu, Aichi)
TEL
0562-46-2311
Homepage URL
sajink@nifty.com
Sponsor or person
Institute
Hyogo Brain and Heart Center at Himeji (National Center for Geriatrics and Gerontology)
Institute
Department
Personal name
Funding Source
Organization
The KAWASAKI Foundation for Medical Science & Medical Welfare and Grants-in-Aid for Scientific Research from the Japan Society for the Promotion of Science.
Organization
Division
Category of Funding Organization
Other
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
兵庫県立姫路循環器病センター
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 20 | 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
The aim of this study was to determine whether pulse wave velocity (PWV), a marker of vascular endothelial impairment and arteriosclerosis, predicts future ischemic stroke in patients who developed acute lacunar infarction. Patients with a first-ever ischemic stroke due to acute lacunar infarction were enrolled in this study. An oscillometric device (Form PWV/ABI;？Omron Colin Co., Ltd., Tokyo, Japan) was used to measure brachial-ankle PWV 1 week after stroke onset. Patients were followed for at least 5 years. The main endpoint of the study was recurrent ischemic stroke. Event-free survival was analyzed using Kaplan-Meier plots and log-rank tests. The risk of recurrent ischemic stroke was estimated using the Cox proportional hazards model. Of the 156 patients (61% male, mean age: 69.2 years) assessed in this study, 29 developed recurrent ischemic stroke. The median brachial-ankle PWV value was 20.4 m/s. Patients with high PWV values had a greater risk of recurrent ischemic stroke than patients with low PWV values (28% vs. 15%, P = 0.08). Kaplan-Meier curve analysis showed that patients with high PWV values had a less favorable (i.e., free of recurrent ischemic stroke) survival time (P = 0.015). A multivariate Cox proportional-hazards model identified high PWV as an independent predictor of recurrent ischemic stroke after adjusting for age, sex, and blood pressure (hazard ratio 2.35, 95% confidence interval, 1.02-5.70, P = 0.044). In patients with acute lacunar infarction, a high PWV predicts a two-fold greater risk of future ischemic stroke, independent of patient age, sex, and blood pressure levels.
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
| 2003 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2003 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Information
Domestic conference: STROKE 2017 (The 42th conference of the Japan Stroke Society)
Title: Increased pulse wave velocity in patients with acute lacunar infarction doubled the risk of future ischemic stroke
International conference: STROKE 2017 (The 42th conference of the Japan Stroke Society)
Title: Increased pulse wave velocity in patients with acute lacunar infarction doubled the risk of future ischemic stroke
Journal: Hypertension Research
Title: Increased pulse wave velocity in patients with acute lacunar infarction doubled the risk of future ischemic stroke
Hypertens Res. 2016 Nov 17. doi: 10.1038/hr.2016.157. [Epub ahead of print]
Management information
Registered date
| 2016 | Year | 07 | Month | 20 | Day |
Last modified on
| 2017 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026779
