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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011883
Receipt No. 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

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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
Email 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
Email yasuka@med.hokudai.ac.jp

Sponsor
Institute Department of Radiation Medicine, Hokkaido University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013871

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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