UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024479 |
|---|---|
| Receipt number | R000028143 |
| Scientific Title | The Impact of FFR and iFR in Patients with Severe Aortic Stenosis |
| Date of disclosure of the study information | 2016/10/19 |
| Last modified on | 2020/11/12 10:57:32 |
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Basic information
Public title
The Impact of FFR and iFR in Patients with Severe Aortic Stenosis
Acronym
The Impact of FFR and iFR in Patients with Severe Aortic Stenosis
Scientific Title
The Impact of FFR and iFR in Patients with Severe Aortic Stenosis
Scientific Title:Acronym
The Impact of FFR and iFR in Patients with Severe Aortic Stenosis
Region
| Japan |
Condition
Condition
Aortic valve stenosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Fractional flow reserve (FFR) is a standard technique to assess the functional severity of coronary artery stenosis in the catheterization laboratory, whereas the instantaneous wave-free ratio (iFR) is being introduced as a new non-pharmacologic-stress index of coronary stenosis severity. The iFR could have great advantages in patients with severe aortic valve stenosis (AS), to evaluate physiologically intermediate coronary artery stenosis, because iFR measurement does not require pharmacologic stress test. However, its performance has not been explored yet. The aim of this research is to establish the impact of iFR in intermediate coronary artery stenosis in patients with severe AS.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Factorial analysis between ischemic score and iFR / FFR
Key secondary outcomes
Factorial analysis between iFR and FFR
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
a. Patients consented with this clinical research.
b. Coronary angiography demonstrated more than 50% diameter stenosis by visual estimation.
Key exclusion criteria
a. contra-indication to ATP
b. lesion with chronic total occlusion
c. acute myocardial infarction within 3 months
d. inadequate lesion for FFR/iFR
e. vessels which connected to bypass graft
f. severe renal dysfunction
g. hemodialysis patients
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Saito |
Organization
Shonankamakura General Hospital
Division name
Department of Cardiology and Catheterization Laboratory
Zip code
Address
1370-1 Okamoto, Kamakura, Kanagawa, Japan
TEL
0467-46-1717
transradial@kamakuraheart.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Futoshi Yamanaka |
Organization
Shonankamakura General Hospital
Division name
Department of Cardiology and Catheterization Laboratory
Zip code
Address
1370-1 Okamoto, Kamakura, Kanagawa, Japan
TEL
0467-46-1717
Homepage URL
futoshi-yamanaka@nifty.com
Sponsor or person
Institute
Shonankamakura General Hospital
Institute
Department
Personal name
Funding Source
Organization
Shonankamakura General Hospital
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
| 2016 | Year | 10 | Month | 19 | 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
| 2015 | Year | 04 | Month | 06 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 06 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 07 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
no comment to declare
Management information
Registered date
| 2016 | Year | 10 | Month | 19 | Day |
Last modified on
| 2020 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028143
