UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002204
Receipt number R000002709
Scientific Title Biochemical parameter seeking for the diagnosis of atherothrombotic brain infarction.
Date of disclosure of the study information 2009/07/28
Last modified on 2011/01/17 09:46:56

* 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

Biochemical parameter seeking for the diagnosis of atherothrombotic brain infarction.

Acronym

biochemical diagnosis of atherothombotic stroke

Scientific Title

Biochemical parameter seeking for the diagnosis of atherothrombotic brain infarction.

Scientific Title:Acronym

biochemical diagnosis of atherothombotic stroke

Region

Japan


Condition

Condition

brain ischemic stroke

Classification by specialty

Medicine in general Endocrinology and Metabolism Neurology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

seeking biochemical parameters that changes specifically on the onset of aterothrombotic brain infarction and confirmation of usefulness as a differentiating marker.

Basic objectives2

Others

Basic objectives -Others

seeding useful biochemical parameters for the diagnosis

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

measures of biochemical parameter that were routinely measured in clinic setting.

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

all of patients with a new brain ischemic stroke

Key exclusion criteria

patients with animia and liver disease

Target sample size

150


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masafumi Kakei

Organization

Jichi Medical University, Saitama Medical Center

Division name

First Department of Internal Medicine

Zip code


Address

1-847 Amanuma Omiya, Saitama, Japan

TEL

048-647-2111

Email



Public contact

Name of contact person

1st name
Middle name
Last name Masafumi Kakei

Organization

Saitama Medical Center

Division name

First Department of Internal Medicine

Zip code


Address

1-847 Amanuma Omiya, Saitama, Japan

TEL

048-647-2111

Homepage URL


Email



Sponsor or person

Institute

Jichi Medical University, Saitama Medical Center

Institute

Department

Personal name



Funding Source

Organization

Jichi Medical University, Saitama Medical Center

Organization

Division

Category of Funding Organization

Other

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

2009 Year 07 Month 28 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

ratio of glycated albumin/glycohemoglobin is increased on admission for the patients with atherothrombotic brain infarction.

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

2006 Year 03 Month 01 Day

Date of IRB


Anticipated trial start date

2006 Year 03 Month 01 Day

Last follow-up date

2011 Year 01 Month 01 Day

Date of closure to data entry

2011 Year 01 Month 01 Day

Date trial data considered complete

2011 Year 01 Month 01 Day

Date analysis concluded

2011 Year 01 Month 01 Day


Other

Other related information

Measures of the ratio of glycated albumin/glycohemoblobin is useful for the diagnosis of atherothrombotic stroke. Other biochemical paramters did not change among the strokes: atherothrombotic, cardioembolic and lacunar brain infarctions.


Management information

Registered date

2009 Year 07 Month 15 Day

Last modified on

2011 Year 01 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002709


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name