UMIN-CTR Clinical Trial

Basic information
Public title	Validation of coronary calcium score derived from CT images for attenuation correction in myocardial perfusion SPECT/CT
Acronym	Validation of coronary calcium score derived from CT images for attenuation correction in myocardial perfusion SPECT/CT
Scientific Title	Validation of coronary calcium score derived from CT images for attenuation correction in myocardial perfusion SPECT/CT
Scientific Title:Acronym	Validation of coronary calcium score derived from CT images for attenuation correction in myocardial perfusion SPECT/CT
Region	Japan

Condition
Condition	Coronary artery disease, heart failure
Classification by specialty	Cardiology Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate the diagnostic impact of coronary calcium score derived from CT images for attenuation correction in myocardial perfusion SPECT/CT.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The relationship of the calcium scores derived from CT images for attenuation correction with the defect size in myocardial SPECT images
Key secondary outcomes	Prognosis (cardiac event, all-cause death) Agreement in calcium scores between coronary CT and CT for attenuation correction

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	95 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who underwent stress myocardial SPECT/CT
Key exclusion criteria	None
Target sample size	250

Research contact person
Name of lead principal investigator	1st name Yukiko Middle name Last name Morita
Organization	National Hospital Organization Sagamihara National Hospital
Division name	Department of Cardiology
Zip code	252-0392
Address	18-1, Sakuradai, Minami-ku, Sagamihara City, Kanagawa, Japan
TEL	0427428311
Email	morita.yukiko.pw@mail.hosp.go.jp

Public contact
Name of contact person	1st name Yukiko Middle name Last name Morita
Organization	National Hospital Organization Sagamihara National Hospital
Division name	Department of Cardiology
Zip code	252-0392
Address	18-1, Sakuradai, Minami-ku, Sagamihara City, Kanagawa, Japan
TEL	0427428311
Homepage URL
Email	morita.yukiko.pw@mail.hosp.go.jp

Sponsor
Institute	Department of Cardiology, National Hospital Organization Sagamihara National Hospital
Institute
Department

Funding Source
Organization	None
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	National Hospital Organization Sagamihara National Hospital
Address	18-1, Sakuradai, Minami-ku, Sagamihara City, Kanagawa, Japan
Tel	0427428311
Email	222-rinri@mail.hosp.go.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

Other administrative information
Date of disclosure of the study information	2021 Year 08 Month 16 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 10 Month 15 Day
Date of IRB	2019 Year 10 Month 15 Day
Anticipated trial start date	2019 Year 10 Month 15 Day
Last follow-up date	2025 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2021 Year 08 Month 09 Day
Last modified on	2021 Year 08 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051342