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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014147
Receipt No. R000016474
Scientific Title Comparison of arteriosclerotic indicators in patients with ischemic stroke
Date of disclosure of the study information 2014/06/04
Last modified on 2015/03/18

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Basic information
Public title Comparison of arteriosclerotic indicators in patients with ischemic stroke
Acronym Comparison of arteriosclerotic indicators in patients with ischemic stroke (cross-sectional study)
Scientific Title Comparison of arteriosclerotic indicators in patients with ischemic stroke
Scientific Title:Acronym Comparison of arteriosclerotic indicators in patients with ischemic stroke (cross-sectional study)
Region
Japan

Condition
Condition Cerebrovascular diseases
Classification by specialty
Medicine in general Neurology Geriatrics
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the arteriosclerotic indicators in patients with ischemic stroke: ankle-brachial index, brachial-ankle pulse wave velocity, and cardio-ankle vascular index
Basic objectives2 Others
Basic objectives -Others Ankle-brachial index (ABI), brachial-ankle pulse wave velocity (baPWV), and cardio-ankle vascular index (CAVI) are surrogate markers of arteriosclerosis. However, analyses of these indicators in patients with ischemic stroke still remain unclear.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The aim of the present study was to compare ABI, baPWV, and CAVI in patients with ischemic stroke and those without a history of stroke.
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 October 2003 and September 2011, we consecutively enrolled patients with first-ever ischemic stroke admitted to the Hyogo Brain and Heart Center at Himeji within 48 hours after stroke onset.
Key exclusion criteria Patients were excluded if following were present: (1) recurrent stroke, (2) stroke of cardioembolism with either high or medium risk potential cardiac sources of embolism based on the Trial of Org 10172 in Acute Stroke Treatment (TOAST) classification, (3) stroke of other determined etiology based on the TOAST classification, (4) ABI <0.9.
Target sample size 800

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Saji
Organization Hyogo Brain and Heart Center at Himeji (Kawasaki Medical School)
Division name Department of Neurology (Department of Stroke Medicine)
Zip code
Address 520 Saisho-ko, Himeji, Hyogo 670-0981, Japan (577 Matsushima, Kurashiki, Okayama 701-0192, Japan)
TEL 079-293-3131
Email 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 701-0192, Japan
TEL 086-462-1111
Homepage URL
Email sajink@nifty.com

Sponsor
Institute Department of Neurology, Hyogo Brain and Heart Center at Himeji (Department of Stroke Medicine, Kawasaki Medical School)
Institute
Department

Funding Source
Organization The KAWASAKI Foundation for Medical Science & Medical Welfare.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2014 Year 06 Month 04 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.nature.com/hr/journal/vaop/ncurrent/full/hr20158a.html
Number of participants that the trial has enrolled
Results
Between October 2003 and September 2011, we consecutively enrolled patients with stroke presenting with large infarcts (diameter more than 1.5cm) attribute to large artery atherosclerosis (LAA) or lacunar infarcts (diameter less than 1.5cm) attribute to small artery disease (SAD). Outpatients without a history stroke were recruited as a control group (CTL). We divided the study period into two terms and assessed recruited patients using two oscillometric devises respectively in each term. Concretely, ABI and baPWV were measured using Form PWV/ABI during the former term. ABI and CAVI were measured using VaSera VS-1500 during the latter term.

A total of 1380 patients with acute ischemic stroke admitted to the Hyogo Brain and Heart Center at Himeji within 48 hours after stroke onset during the study period. Among them, we excluded 488 patients with cardioembolism and 384 patients with other determined etiology. Of 508 remaining patients, we excluded 126 patients; 69 recurrent stroke, 39 lack of data, and 18 having ABI <0.9. Hence, 382 patients with first-ever ischemic stroke consisting of 280 as SAD and 102 as LAA were enrolled. As a control group (CTL), 460 outpatients consisting of 240 recruited in the first period and 220 recruited in the second period were also enrolled in this study. Finally, we analyzed 842 patients.
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 10 Month 01 Day
Date of IRB
Anticipated trial start date
2003 Year 10 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 04 Month 30 Day
Date analysis concluded
2014 Year 05 Month 31 Day

Other
Other related information For further details, please see the article.

Management information
Registered date
2014 Year 06 Month 03 Day
Last modified on
2015 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016474

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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