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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032605
Receipt No. R000037179
Scientific Title The Impact of the Sampling Rate of Dynamic Myocardial Computed Tomography Perfusion on the Quantitative Assessment of Myocardial Blood Flow
Date of disclosure of the study information 2018/05/16
Last modified on 2019/05/25

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Basic information
Public title The Impact of the Sampling Rate of Dynamic Myocardial Computed Tomography Perfusion on the Quantitative Assessment of Myocardial Blood Flow
Acronym Impact of Sampling Rate on CT-MBF
Scientific Title The Impact of the Sampling Rate of Dynamic Myocardial Computed Tomography Perfusion on the Quantitative Assessment of Myocardial Blood Flow
Scientific Title:Acronym Impact of Sampling Rate on CT-MBF
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this study is to investigate the influence of reducing the shot-to-shot sampling rate of dynamic myocardial computed tomography perfusion (CTP) scans on the computation of CTP-derived myocardial blood flow (CT-MBF) and diagnostic performance for detecting myocardial perfusion abnormalities.
Basic objectives2 Others
Basic objectives -Others influence
diagnostic performance
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The global CTMBFs with 2RR, 3RR, and 4RR sampling are compared with that with 1RR sampling as a reference, using the equivalence test with Bonferroni correction.
Key secondary outcomes The Pearson rank correlation test is used to assess the relationship between the global CTMBF with 1RR sampling and that with 2RR, 3RR, or 4RR sampling. The equivalence test with Bonferroni correction is used to compare segmental CT-MBFs with 2RR, 3RR, and 4RR sampling to that with 1RR sampling for normal and abnormal myocardial segments that were assessed with cardiac MR. The areas under the receiver operating characteristic curve of segmental CT-MBF with 2RR, 3RR, and 4RR sampling are compared with that with 1RR sampling.

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

Not applicable
Gender Male and Female
Key inclusion criteria Patients who underwent stress dynamic CTP for the assessment of CAD between July 2013 and November 2017.
Key exclusion criteria (1) acute myocardial infarction (<30 days from the onset), (2) cardiomyopathy, (3) left ventricular ejection fraction <20%, (4) atrial fibrillation, (5) an atrioventricular block greater than the first degree, (6) complete left bundle branch block, (7) history of percutaneous coronary intervention or coronary artery bypass grafting, (8) poor cardiac MR image quality, and (9) an inappropriate CTP dataset such as that with insufficient image quality, misaligned scan coverage, and delayed data acquisition of dynamic CTP causing a shorter baseline (before upslope) of the TAC in the ascending aorta.
Target sample size 180

Research contact person
Name of lead principal investigator
1st name Takahrio
Middle name
Last name Yokoi
Organization Ehime University Graduate School of Medicine
Division name Radiology
Zip code 7910295
Address Shitsukawa, Toon, Ehime, Japan
TEL +81-89-960-5371
Email mr.taka451@gmail.com

Public contact
Name of contact person
1st name Takahiro
Middle name
Last name Yokoi
Organization Ehime University Graduate School of Medicine
Division name Radiology
Zip code 7910295
Address Shitsukawa, Toon, Ehime, Japan
TEL +81-89-960-5371
Homepage URL
Email mr.taka451@gmail.com

Sponsor
Institute Ehime University Graduate School of Medicine
Institute
Department

Funding Source
Organization Ehime University Graduate School of Medicine
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 Ehime University Graduate School of Medicine
Address Shitsukawa, Toon , Ehime
Tel 0899605371
Email mr.taka451@gmail.com

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
2018 Year 05 Month 16 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 120
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
2016 Year 05 Month 10 Day
Date of IRB
2016 Year 03 Month 31 Day
Anticipated trial start date
2016 Year 05 Month 10 Day
Last follow-up date
2018 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information retrospective

Management information
Registered date
2018 Year 05 Month 16 Day
Last modified on
2019 Year 05 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037179

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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