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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023239
Receipt No. 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

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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
Email 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
Email sajink@nifty.com

Sponsor
Institute Hyogo Brain and Heart Center at Himeji (National Center for Geriatrics and Gerontology)
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026779

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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