UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015085
Receipt number R000017533
Scientific Title The Utility of Late Gadolinium Enhancement in Takayasu Arteritis.
Date of disclosure of the study information 2014/09/08
Last modified on 2014/09/08 20:44:38

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Basic information

Public title

The Utility of Late Gadolinium Enhancement in Takayasu Arteritis.

Acronym

The Utility of Late Gadolinium Enhancement in Takayasu Arteritis.

Scientific Title

The Utility of Late Gadolinium Enhancement in Takayasu Arteritis.

Scientific Title:Acronym

The Utility of Late Gadolinium Enhancement in Takayasu Arteritis.

Region

Japan


Condition

Condition

Takayasu arteritis

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the utility of LGE in patients with Takayasu arteritis retrospectivelly.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

the utility of LGE in patients with Takayasu arteritis

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

Takayasu arteritis patients who underwent aortic contrast enhanced MRI between March 2011 and May 2012

Key exclusion criteria

insufficient data to assess wall thickness, or the lack of an image field of view to analyze the LGE.

Target sample size

57


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mitsuaki Isobe

Organization

Tokyo Medical and Dental University

Division name

Cardiovascular Medicine

Zip code


Address

1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519, Japan

TEL

03-5803-5951

Email

isobemi.cvm@tmd.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Mitsuaki Isobe

Organization

Tokyo Medical and Dental University

Division name

Cardiovascular Medicine

Zip code


Address

1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519, Japan

TEL

03-5803-5951

Homepage URL


Email

isobemi.cvm@tmd.ac.jp


Sponsor or person

Institute

Division of Cardiovascular Medicine

Institute

Department

Personal name



Funding Source

Organization

donation money for research

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Cardiovascular Imaging Clinic

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

東京医科歯科大学 循環制御内科学(東京都)
Division of Cardiovascular medicine, Tokyo Medical and Dental University


Other administrative information

Date of disclosure of the study information

2014 Year 09 Month 08 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


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

No longer recruiting

Date of protocol fixation

2014 Year 09 Month 03 Day

Date of IRB


Anticipated trial start date

2014 Year 09 Month 09 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Takayasu arteritis patients who underwent aortic MRI between March 2011 and May 2012 were studied retrospectively. Patients were divided into two groups (Active/ Inactive) according to disease activity, and the results of qualitative / quantitative analysis were compared between the two groups.


Management information

Registered date

2014 Year 09 Month 08 Day

Last modified on

2014 Year 09 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017533


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name