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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010606
Receipt No. R000012400
Scientific Title Evaluation of severity of coronary artery aneurysm in Kawasaki disease by Z-score of internal diameter
Date of disclosure of the study information 2013/05/01
Last modified on 2018/03/10

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Basic information
Public title Evaluation of severity of coronary artery aneurysm in Kawasaki disease by Z-score of internal diameter
Acronym Z-score project 2nd stage in Kawasaki disease
Scientific Title Evaluation of severity of coronary artery aneurysm in Kawasaki disease by Z-score of internal diameter
Scientific Title:Acronym Z-score project 2nd stage in Kawasaki disease
Region
Japan

Condition
Condition Kawasaki disease
Classification by specialty
Cardiology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To optimize cut-off points of internal diameter Z-scores of coronary artery aneurysms in patients with Kawasaki disease for prognostic identification.
Basic objectives2 Others
Basic objectives -Others Validity of Z-scores of measurements
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Optimal cut-off points of internal diameter Z-scores of coronary artery aneurysms for identification of thrombus formation, stenosis, and obstruction.
Key secondary outcomes Optimal cut-off points of internal diameter Z-scores of coronary artery aneurysms for identification of regression or events including angina,myocardial infarction,and cardiac death.

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 Patients who received coronary angiography, enhanced CT,or MRI for evaluation of coronary arteries from January,1992 to December,2011 after onset of Kawasaki disease at the age of 18 and younger.
Key exclusion criteria 1) Echocardiographic data of coronary artery diameters are not available in acute phase.
2) First evaluation of coronary arteries by coronary angiography, enhanced CT,or MRI was done in another institutions.
3) Underlying diseases which affect coronary artery lesions or life prognosis is present.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaru Miura
Organization Tokyo Metropolitan Children's Medical Center
Division name Division of Cardiology
Zip code
Address 2-8-29, Musashi-dai, Fuchu,Tokyo
TEL 042-300-5111
Email masaru_miura@tmhp.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoya Fukushima
Organization Tokyo Metropolitan Children's Medical Center
Division name Clinical Research Support Center
Zip code
Address 2-8-29, Musashi-dai, Fuchu,Tokyo
TEL 042-300-5111
Homepage URL http://raise.umin.jp/zsp2/
Email naoya_fukushima@tmhp.jp

Sponsor
Institute Tokyo Metropolitan Children's Medical Center
Institute
Department

Funding Source
Organization Japanese Kawasaki Disease Research Center
Organization
Division
Category of Funding Organization Non profit foundation
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
2013 Year 05 Month 01 Day

Related information
URL releasing protocol http://raise.umin.jp/zsp2/
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The aim of this study was to clarify the relationship of the Z-score to time-dependent occurrence of coronary events (CE)in patients
 with Kawasaki disease (KD)  patients with CAA. We surveyed 1006 Kawasaki disease patients < 19 years old who received a coronary angiography. The 10-year event-free survival rate for coronary events was 100%, 94%, and 52% in males and 100%, 100%, and 75% in females for small, medium, and large aneurysms, respectively. Large aneurysms, male sex, and resistance to intravenous immunoglobulin therapy were associated with coronary events.Careful management is essential for males and treatment-resistant patients with large coronary artery aneurysms based on the internal
 diameter Z-score.
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
2012 Year 04 Month 13 Day
Date of IRB
Anticipated trial start date
2012 Year 06 Month 01 Day
Last follow-up date
2014 Year 05 Month 31 Day
Date of closure to data entry
2014 Year 05 Month 31 Day
Date trial data considered complete
2016 Year 04 Month 30 Day
Date analysis concluded
2016 Year 05 Month 31 Day

Other
Other related information Results will be disclosed on the home page of RAISE Study. The article has been accepted in JAMA Pediatr.

Management information
Registered date
2013 Year 04 Month 27 Day
Last modified on
2018 Year 03 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012400

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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