UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029899 |
|---|---|
| Receipt number | 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 21:28:55 |
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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
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
hdnb69tkg@gmail.com
Sponsor or person
Institute
Department of Radiology, Iwate Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034155
