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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000015085
Receipt No. 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

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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
Institute Division of Cardiovascular Medicine
Institute
Department

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
URL(English) https://upload.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


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