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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029899
Receipt No. R000034155
Scientific Title A novel interpretation method of fractional flow reserve derived from CT (FFR-CT)
Date of disclosure of the study information 2017/12/30
Last modified on 2018/05/26

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Basic information
Public title A novel interpretation method of fractional flow reserve derived from CT (FFR-CT)
Acronym A novel interpretation method of fractional flow reserve derived from CT (FFR-CT)
Scientific Title A novel interpretation method of fractional flow reserve derived from CT (FFR-CT)
Scientific Title:Acronym A novel interpretation method of fractional flow reserve derived from CT (FFR-CT)
Region
Japan

Condition
Condition Ischemic coronary disease
Classification by specialty
Medicine in general Cardiology Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In this study, we explore which paramers derived from FFRCT have better diagnostic performance for the detection of ischemia compared with invasive FFR as the refference standard.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary endpoint was diagnostic characteristics including area under curve (AUC), accuracy, sensitivity, and specificity for detection of ischemia of CCTA and quantitative parameters derived from FFR-CT.
Key secondary outcomes

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
30 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Consecutive patients who underwent CCTA with FFR-CT analysis followed by invasive FFR measurement
Key exclusion criteria 1) Patients with history of prior coronary artery bypass graft surgery or percutaneous coronary intervention
2 )Patients with unstable symptom.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidenobu Takagi
Organization Iwate Medical University
Division name Department of Radiology
Zip code
Address 19-1, Uchimaru, Morioka, Iwate
TEL 019-651-5111
Email hdnb69tkg@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Hidenobu Takagi
Organization Iwate Medical University
Division name Department of Radiology
Zip code
Address 19-1, Uchimaru, Morioka, Iwate
TEL 019-651-5111
Homepage URL
Email hdnb69tkg@gmail.com

Sponsor
Institute Department of Radiology, Iwate Medical University
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
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
2017 Year 12 Month 30 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
2017 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
2017 Year 10 Month 31 Day
Date trial data considered complete
2017 Year 10 Month 31 Day
Date analysis concluded
2018 Year 07 Month 31 Day

Other
Other related information This study is retrospective observational study.
Study enrollment has already closed.

Management information
Registered date
2017 Year 11 Month 09 Day
Last modified on
2018 Year 05 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034155

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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