UMIN-CTR Clinical Trial

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	52
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2020 Year 11 Month 12 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
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	2020 Year 03 Month 31 Day

Other
Other related information	nothing

Management information
Registered date	2019 Year 02 Month 03 Day
Last modified on	2020 Year 08 Month 05 Day

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