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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024768
Receipt No. R000028490
Scientific Title A registry study of Kawasaki disease patients with coronary artery aneurysms
Date of disclosure of the study information 2016/11/08
Last modified on 2017/11/10

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Basic information
Public title A registry study of Kawasaki disease patients with coronary artery aneurysms
Acronym KIDCAR
Scientific Title A registry study of Kawasaki disease patients with coronary artery aneurysms
Scientific Title:Acronym KIDCAR
Region
Japan

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

Objectives
Narrative objectives1 To clarify time-dependent incidence of coronary events including thrombosis, stenosis, and occlusion in Kawasaki disease patients with coronary artery aneurysms.
Basic objectives2 Others
Basic objectives -Others To study time-dependent incidence of acute coronary syndrome and regression of coronary artery aneurysm.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of coronary events including thrombosis, stenosis, and occlusion
Key secondary outcomes 1) Incidence of major cardiac events, or acute coronary syndrome including unstable angina, myocardial infarction, and cardiac-related death
2) Incidence of regression of coronary artery aneurysms
3) Relation of medications to occurence of coronary events, major cardiac events, and regression

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 1) Petinets with first onset of Kawasaki disease or recurrent onset without previous coronary artery aneuryms
2) Patients with absolute values of coronary artery dimaeters, 4 mm and more or z-scores, 5.0 and more on 30th day of illness and later
Key exclusion criteria 1) Patients with recurent onset of Kawasaki disease with previous coronary artery aneuryms
2) Patients with absolute values of coronary artery dimaeters, less than 4 mm and z-scores, less than 5.0 on 30th day of illness and later
3) Patients who attending physicians consider to be inappropriate
Target sample size 600

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, Musashidai, Fuchu, Tokyo, 183-8561, Japan
TEL 042-300-5111
Email mmiura-pccs@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koichi Miyata
Organization Tokyo Metropolitan Children's Medical Center
Division name Division of Cardiology
Zip code
Address 2-8-29, Musashidai, Fuchu, Tokyo, 183-8561, Japan
TEL 042-300-5111
Homepage URL
Email koichi_miyata@tmhp.jp

Sponsor
Institute Ckinical Research Support Center, Tokyo Metropolitan Children's Medical Center
Institute
Department

Funding Source
Organization Japanese Society of Kawasaki Disease
Clinical Research for Tokyo Metropolitan Hospitals
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
2016 Year 11 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 Open public recruiting
Date of protocol fixation
2016 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Nothing particular

Management information
Registered date
2016 Year 11 Month 08 Day
Last modified on
2017 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028490

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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