UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040574 |
|---|---|
| Receipt number | 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 10:37:15 |
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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
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
suzuki.yasuyuki@nihon-u.ac.jp
Sponsor or person
Institute
Department of Cardiology, Nihon University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046309
