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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035757
Receipt No. R000040731
Scientific Title Validation of Japanese Normal Database on Semi-conductor Gamma Camera
Date of disclosure of the study information 2019/03/25
Last modified on 2019/04/30

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Basic information
Public title Validation of Japanese Normal Database on Semi-conductor Gamma Camera
Acronym Normal Database of Semi-conductor Gamma Camera
Scientific Title Validation of Japanese Normal Database on Semi-conductor Gamma Camera
Scientific Title:Acronym Normal Database of Semi-conductor Gamma Camera
Region
Japan

Condition
Condition Coronary artery disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Relationship between computer and human reading
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Coefficient value between computer and human reading.
Key secondary outcomes Rate of case in terms of contours change

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
20 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Coronary artery disease (CAD)
or suspicious CAD
Key exclusion criteria Inappropriate cases of invesitagors
Target sample size 48

Research contact person
Name of lead principal investigator
1st name Naoya
Middle name
Last name Matsumoto
Organization Nihon University Hospital
Division name Department of Cardiology
Zip code 101-8309
Address 1-6, Kanda Surugadai, Chiyoda-ku, Tokyo, Japan
TEL 03-3293-1711
Email matsumoto.naoya@nihon-u.ac.jp

Public contact
Name of contact person
1st name Naoya
Middle name
Last name Matsumoto
Organization Nihon University Hospital
Division name Department of Cardiology
Zip code 101-8309
Address 1-6, Kanda Surugadai, Chiyoda-ku, Tokyo, Japan
TEL 03-3293-1711
Homepage URL
Email matsumoto.naoya@nihon-u.ac.jp

Sponsor
Institute Japanese Society of Nuclear Cardiology
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization IRB, Nihon University Hospital
Address 1-6, Kanda Surugadai, Chiyoda-ku, Tokyo, Japan
Tel 03-3293-1711
Email matsumoto.naoya@nihon-u.ac.jp

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 日本大学病院、金沢大学、榊原記念病院、公立松任中央病院、名古屋第二赤十字病院、国立循環器病研究センター、姫路循環器病センター

Other administrative information
Date of disclosure of the study information
2019 Year 03 Month 25 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 Enrolling by invitation
Date of protocol fixation
2019 Year 03 Month 25 Day
Date of IRB
2019 Year 03 Month 14 Day
Anticipated trial start date
2019 Year 03 Month 25 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information nothing

Management information
Registered date
2019 Year 02 Month 03 Day
Last modified on
2019 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040731

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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