UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012131 |
|---|---|
| Receipt number | R000013332 |
| Scientific Title | Diagnostic performance of combined myocardial perfusion imaging and dual energy CT using 320-detector CT |
| Date of disclosure of the study information | 2013/10/29 |
| Last modified on | 2018/07/04 19:24:40 |
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Basic information
Public title
Diagnostic performance of combined myocardial perfusion imaging and dual energy CT using 320-detector CT
Acronym
Diagnostic performance of combined myocardial perfusion imaging and dual energy CT using 320-detector CT
Scientific Title
Diagnostic performance of combined myocardial perfusion imaging and dual energy CT using 320-detector CT
Scientific Title:Acronym
Diagnostic performance of combined myocardial perfusion imaging and dual energy CT using 320-detector CT
Region
| Japan |
Condition
Condition
coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To detecte myocardial perfusion abnormalities at cardiac CT
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
myocardial perfusion abnormalities
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Patients with coronary artery disease
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(a) Patients with coronary artery disease
(b) Patients who are scheduled to perform SPECT or CAG
(c) Age (40< year-old)
(d) Patients given written informed consent
Key exclusion criteria
(a) Patients who had a previous allergic reaction to iodinated contrast material
(b) Poor conditions
(c) Asthma
(d) Cerebral hemorrhage
(e) Arrhythmia
(f) Elevated serum creatinine level
(g) Women who were potentially pregnant
(h) Patients who are considered inappropriate for enrollement in this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Awai |
Organization
Hiroshima University
Division name
Diagnostic Radiology
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5257
awai@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fuminari Tatsugami |
Organization
Hiroshima University
Division name
Diagnostic Radiology
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5257
Homepage URL
sa104@rg8.so-net.ne.jp
Sponsor or person
Institute
Department of Diagnostic Radiology, Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Toshiba Medical
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 10 | Month | 29 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 06 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 26 | Day |
Last modified on
| 2018 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013332
