UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014147
Receipt number 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 12:26:07

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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