UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010606
Receipt number 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 09:25:07

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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 or person

Institute

Tokyo Metropolitan Children's Medical Center

Institute

Department

Personal name



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

Value
https://center6.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