UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043429 |
|---|---|
| Receipt number | R000049586 |
| Scientific Title | Fractional Flow Reserve and Instantaneous Wave-Free Ratio Discordance in Patients with Severe Aortic Valve Stenosis |
| Date of disclosure of the study information | 2021/03/01 |
| Last modified on | 2022/04/07 22:21:13 |
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Basic information
Public title
Fractional Flow Reserve and Instantaneous Wave-Free Ratio Discordance in Patients with Severe Aortic Valve Stenosis
Acronym
Fractional Flow Reserve and Instantaneous Wave-Free Ratio Discordance in Patients with Severe Aortic Valve Stenosis
Scientific Title
Fractional Flow Reserve and Instantaneous Wave-Free Ratio Discordance in Patients with Severe Aortic Valve Stenosis
Scientific Title:Acronym
Fractional Flow Reserve and Instantaneous Wave-Free Ratio Discordance in Patients with Severe Aortic Valve Stenosis
Region
| Japan |
Condition
Condition
Aortic stenosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the frequency and factors of FFR and iFR diagnostic discrepancies in patients with severe aortic stenosis.
Basic objectives2
Others
Basic objectives -Others
To investigate the changes in FFR and iFR after treatment of severe aortic stenosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate diagnostic discrepancy of FFR and iFR in patients with severe aortic stenosis.
Key secondary outcomes
To investigate the changes in FFR and iFR after treatment of severe aortic stenosis
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent FFR and iFR assessments for moderate coronary artery stenosis with aortic valve stenosis
Key exclusion criteria
None
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Futoshi |
| Middle name | |
| Last name | Yamanaka |
Organization
Shonan Kamakura General Hospital
Division name
Department of Cardiology
Zip code
2478533
Address
1370-1, Okamoto, Kamakura, Kanagawa
TEL
0467461717
futoshi-yamanaka@nifty.com
Public contact
Name of contact person
| 1st name | Futoshi |
| Middle name | |
| Last name | Yamanaka |
Organization
Shonan Kamakura General Hospital
Division name
Department of Cardiology
Zip code
2478533
Address
1370-1, Okamoto, Kamakura, Kanagawa
TEL
0467461717
Homepage URL
futoshi-yamanaka@nifty.com
Sponsor or person
Institute
Department of Cardiology, Shonan Kamakura General 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
The Tokushukai Group Ethics Committee
Address
Emina Building 3F, 1-8-7, Koji-machi, Chiyoda-ku, Tokyo, Japan
Tel
03-3263-4801
mirai-ec1@mirai-iryo.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
湘南鎌倉総合病院循環器科
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 01 | 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
| 2020 | Year | 03 | Month | 04 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 26 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 02 | Month | 24 | Day |
Last modified on
| 2022 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049586
