UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000040574
Receipt No. R000046309
Scientific Title Incremental predictive value of coronary calcium score in risk stratification of patients evaluated normal and mild ischemia using nuclear myocardial perfusion imaging with semiconductor scanner
Date of disclosure of the study information 2020/06/10
Last modified on 2020/05/29 (Ver. 1)

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Basic information
Public title Incremental predictive value of coronary calcium score in risk stratification of patients evaluated normal and mild ischemia using nuclear myocardial perfusion imaging with semiconductor scanner
Acronym Incremental predictive value of coronary calcium score in risk stratification of patients evaluated normal and mild ischemia using nuclear myocardial perfusion imaging with semiconductor scanner
Scientific Title Incremental predictive value of coronary calcium score in risk stratification of patients evaluated normal and mild ischemia using nuclear myocardial perfusion imaging with semiconductor scanner
Scientific Title:Acronym Incremental predictive value of coronary calcium score in risk stratification of patients evaluated normal and mild ischemia using nuclear myocardial perfusion imaging with semiconductor scanner
Region
Japan

Condition
Condition Ischemic heart disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to clarify incremental predictive value of coronary calcium score in risk stratification of patients scored normal and mild ischemia using nuclear myocardial perfusion imaging with semiconductor scanner
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incremental predictive value of coronary calcium score (cutoff value 300) in risk stratification of coronary revascularization among patients who evaluated normal and mild ischemia using nuclear myocardial perfusion imaging with semiconductor scanner.
Key secondary outcomes

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 Patients who performed calculation of coronary calcium score and nuclear myocardial perfusion imaging with semiconductor scanner within 3 months.
Key exclusion criteria Patients who have known history of coronary artery disease or revascularization including percutaneous coronary intervention (PCI) and coronary artery bypass surgery (CABG) in addition to the patients with chronic kidney disease treated by hemodialisis.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name YASUYUKI
Middle name
Last name SUZUKI
Organization Nihon University Hospital
Division name Department of Cardiology
Zip code 101-8309
Address 1-6 Kandasurugadai, Chiyodaku, Tokyo, Japan
TEL 03-3293-1711
Email suzuki.yasuyuki@nihon-u.ac.jp

Public contact
Name of contact person
1st name YASUYUKI
Middle name I
Last name SUZUKI
Organization Nihon University Hospital
Division name Department of Cardiology
Zip code 101-8309
Address 1-6 Kandasurugadai, Chiyodaku, Tokyo, Japan
TEL 03-3293-1711
Homepage URL
Email suzuki.yasuyuki@nihon-u.ac.jp

Sponsor
Institute Department of Cardiology, Nihon University Hospital
Institute
Department

Funding Source
Organization None
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 The review board of clinical research of NIhon University Hospital
Address 1-6 Kandasurugadai, Chiyodaku, Tokyo, 101-8309, Japan
Tel 03-3293-1711
Email tani.shigemasa@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

Other administrative information
Date of disclosure of the study information
2020 Year 06 Month 10 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 528
Results 
Coronary calcium score (cutoff value 300) significantly stratified risk of coronary revascularization in patients woh scored normal and mild ischemia using myocardial perfusion imaging with semiconductor scanner.
Results date posted
2020 Year 05 Month 29 Day
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
2019 Year 06 Month 30 Day
Date of IRB
2019 Year 07 Month 11 Day
Anticipated trial start date
2019 Year 06 Month 30 Day
Last follow-up date
2019 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study

Management information
Registered date
2020 Year 05 Month 29 Day
Last modified on
2020 Year 05 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046309