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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011291
Receipt No. R000012609
Scientific Title Radiation dose reduction for coronary artery calcium scoring at CT with adaptive iterative reconstruction
Date of disclosure of the study information 2013/07/29
Last modified on 2015/08/28

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Basic information
Public title Radiation dose reduction for coronary artery calcium scoring at CT with adaptive iterative reconstruction
Acronym Radiation dose reduction for coronary artery calcium scoring at CT with iterative reconstruction
Scientific Title Radiation dose reduction for coronary artery calcium scoring at CT with adaptive iterative reconstruction
Scientific Title:Acronym Radiation dose reduction for coronary artery calcium scoring at CT with iterative reconstruction
Region
Japan

Condition
Condition coronary artery disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the possibility of reducing the radiation dose for coronary artery calcium scoring at CT with iterative reconstruction.
Basic objectives2 Others
Basic objectives -Others possibility of reducing the radiation dose
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Agatston score
Key secondary outcomes

Base
Study type

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) Age (40< year-old)
(c) Patients given written informed consent
Key exclusion criteria (a) Poor conditions
(b) Patients who had a previous allergic reaction to iodinated contrast material
(c) Asthma
(d) Elevated serum creatinine level
(e) Arrhythmia
(f) Patients with history of cardiac surgery, coronary stents.
(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
Email 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
Email sa104@rg8.so-net.ne.jp

Sponsor
Institute Department of Diagnostic Radiology, Hiroshima University
Institute
Department

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
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 07 Month 29 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/25754302
Number of participants that the trial has enrolled
Results
The use of AIDR 3D made it possible to reduce the radiation dose by 67 % for CAC scoring without impairing the quantification of coronary calcification.
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
2013 Year 05 Month 20 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 29 Day
Last follow-up date
Date of closure to data entry
2013 Year 12 Month 31 Day
Date trial data considered complete
2014 Year 12 Month 31 Day
Date analysis concluded
2015 Year 03 Month 05 Day

Other
Other related information

Management information
Registered date
2013 Year 07 Month 26 Day
Last modified on
2015 Year 08 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012609

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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