UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical survey to clarify the association between arterial stiffness and cerebrovascular diseases
Title of the study (Brief title)	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	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)
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	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)
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2003 Year 08 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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.
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