UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011883 |
|---|---|
| Receipt number | R000013871 |
| Scientific Title | Quantification of Myocardial Blood Flow Using Low-Dose Dynamic 320-row Multi-detector CT as Compared With 15O-H2O PET |
| Date of disclosure of the study information | 2013/10/01 |
| Last modified on | 2013/09/27 11:52:35 |
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Basic information
Public title
Quantification of Myocardial Blood Flow Using Low-Dose Dynamic 320-row Multi-detector CT as Compared With 15O-H2O PET
Acronym
Quantification of Myocardial Blood Flow Using Low-Dose Dynamic 320-row Multi-detector CT as Compared With 15O-H2O PET
Scientific Title
Quantification of Myocardial Blood Flow Using Low-Dose Dynamic 320-row Multi-detector CT as Compared With 15O-H2O PET
Scientific Title:Acronym
Quantification of Myocardial Blood Flow Using Low-Dose Dynamic 320-row Multi-detector CT as Compared With 15O-H2O PET
Region
| Japan |
Condition
Condition
coronary artery disease
Classification by specialty
| Cardiology | Radiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study is conducted to establish a method for calculating whole-myocardium myocardial blood flow (MBF) and coronary flow reserve (CFR) using low-dose dynamic 320-row MDCT, with validation against 15O-H2O PET, and to compare MBF and CFR in normal subjects and patients with coronary artery disease.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MDCT and 15O-H2O PET perfusion imaging are undergone within a 2-week period.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
pilot group
Interventions/Control_2
validation group
Interventions/Control_3
coronary artery disease group
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 volunteer who is over 20 years old and gives written informed consent for this study.
2 in or out patients who are over 20 years old and were diagnosed as coronary artery disease (CAD) or suspected CAD, and give written informed consent for this study.
Key exclusion criteria
subjects who can not give written informed consent for this study, or can not undergo this study for her or his disease, or have an impaired renal function.
Target sample size
65
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nagara Tamaki |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Nuclear Medicine
Zip code
Address
N15W7, Kita-ku, Sapporo, Hokkaido, 060-8638, Japan
TEL
011-706-5152
natamaki@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuka Kikuchi |
Organization
Hokkaido University Hospital
Division name
Department of Diagnostic and Interventional Radiology
Zip code
Address
N15W7, Kita-ku, Sapporo, Hokkaido, 060-8638, Japan
TEL
011-706-5977
Homepage URL
yasuka@med.hokudai.ac.jp
Sponsor or person
Institute
Department of Radiation Medicine, Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
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 | 01 | 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
Completed
Date of protocol fixation
| 2012 | Year | 07 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 27 | Day |
Last modified on
| 2013 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013871
