UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043541 |
|---|---|
| Receipt number | R000045414 |
| Scientific Title | Assessment of Coronary Hemodynamics after Transcatheter Aortic Valve Implantation. |
| Date of disclosure of the study information | 2021/03/08 |
| Last modified on | 2023/11/14 15:42:59 |
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Basic information
Public title
Assessment of Coronary Hemodynamics after Transcatheter Aortic Valve Implantation.
Acronym
Assessment of Coronary Hemodynamics after Transcatheter Aortic Valve Implantation.
Scientific Title
Assessment of Coronary Hemodynamics after Transcatheter Aortic Valve Implantation.
Scientific Title:Acronym
Assessment of Coronary Hemodynamics after Transcatheter Aortic Valve Implantation.
Region
| Japan |
Condition
Condition
Aortic valve stenosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessment of changes in FFR and iFR in the subacute and chronic phases after TAVI.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Changes in FFR and iFR in the subacute and chronic phases after TAVI
Key secondary outcomes
exploratory assessment of changes in FFR and iFR after TAVI
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
1)with severe aortic valve stenosis(aortic valve area less than 1cm2 and more than peak velocity 4.0m/s)
2)with moderate coronary artery stenosis, 30-70%
3)with over 20 years old
4)with sufficient informed consent
Key exclusion criteria
1)Patients with acute coronary syndrome
2)Patients with chronic kidney disease
3)Pregnant female
Target sample size
25
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
Shonan Kamakura General Hospital
Institute
Department
Personal name
Funding Source
Organization
Shonan Kamakura 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
Tokushukai Group Institutional Review Board
Address
1-8-7 Koujimachi, Chiyoda-ku, Tokyo
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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
21
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 | 11 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 18 | Day |
Last follow-up date
| 2022 | Year | 12 | 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 | 03 | Month | 07 | Day |
Last modified on
| 2023 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045414
