UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045101 |
|---|---|
| Receipt number | R000051342 |
| Scientific Title | Validation of coronary calcium score derived from CT images for attenuation correction in myocardial perfusion SPECT/CT |
| Date of disclosure of the study information | 2021/08/16 |
| Last modified on | 2021/08/09 16:12:54 |
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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
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
morita.yukiko.pw@mail.hosp.go.jp
Sponsor or person
Institute
Department of Cardiology, National Hospital Organization Sagamihara National Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051342
