UMIN-CTR Clinical Trial

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
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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
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Research case data
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