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

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 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


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

Value
https://center6.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