UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052002 |
|---|---|
| Receipt number | R000059356 |
| Scientific Title | Diagnostic accuracy of vessel fractional flow reserve compared to conventional diagnostic tools in patients with coronary artery stenosis. |
| Date of disclosure of the study information | 2023/08/25 |
| Last modified on | 2023/08/25 03:38:04 |
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Basic information
Public title
Diagnostic accuracy of vessel fractional flow reserve compared to conventional diagnostic tools in patients with coronary artery stenosis.
Acronym
Diagnostic accuracy of vessel fractional flow reserve
Scientific Title
Diagnostic accuracy of vessel fractional flow reserve compared to conventional diagnostic tools in patients with coronary artery stenosis.
Scientific Title:Acronym
Diagnostic accuracy of vessel fractional flow reserve compared to conventional diagnostic tools in patients with coronary artery stenosis.
Region
| Japan |
Condition
Condition
IHD: Ischemic Heart Disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
we aim to investigate the relationship between vFFR and other conventional physiological assessment tools.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy assessment and other sub-analyses
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with stable or unstable angina, and non-ST-elevation acute coronary syndrome who had undergone physiological assessments [wire-based FFR, instantaneous wave-free ratio (iFR), resting full-cycle ratio (RFR), and/or coronary computed tomography angiography-derived FFR (FFRCT)] before percutaneous coronary intervention were included for the present analysis.
Key exclusion criteria
The exclusion criteria were ST-elevation myocardial infarction, previous coronary artery bypass grafting, cardiogenic shock, and adenosine intolerance.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Asami |
Organization
Mitsui Memorial Hospital
Division name
Division of Cardiology
Zip code
101-8643
Address
Izumicho-1, Kanda, Chiyoda-ku, Tokyo
TEL
0338629111
asami560725@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Masahiko |
| Middle name | |
| Last name | Asami |
Organization
Mitsui Memorial Hospital
Division name
Divison of Cardiology
Zip code
101-8643
Address
Izumicho-1, Kanda, Chiyoda-ku, Tokyo
TEL
0338629111
Homepage URL
asami560725@yahoo.co.jp
Sponsor or person
Institute
Mitsui Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Mitsui Memorial Hospital
Address
Izumicho-1, Kanda, Chiyoda-ku, Tokyo
Tel
0338629111
c-uno@mitsuihosp.or.jp
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
| 2023 | Year | 08 | Month | 25 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 10 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2023 | Year | 08 | Month | 25 | Day |
Last modified on
| 2023 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059356
