UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030915 |
|---|---|
| Receipt number | R000035301 |
| Scientific Title | respiratory function after transcatherter aortic valve implantation |
| Date of disclosure of the study information | 2018/01/21 |
| Last modified on | 2018/07/23 09:59:06 |
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Basic information
Public title
respiratory function after transcatherter aortic valve implantation
Acronym
respiratory function after TAVI
Scientific Title
respiratory function after transcatherter aortic valve implantation
Scientific Title:Acronym
respiratory function after TAVI
Region
| Japan |
Condition
Condition
aortic valve stenosis
Classification by specialty
| Cardiology | Vascular surgery | Anesthesiology |
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to investigate respiratory function early stage after TAVI
Basic objectives2
Others
Basic objectives -Others
to investigate factors that influence respiratory function after TAVI
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
respiratory function from postoperative day to one week after TAVI
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
to implement respiratory function test
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 undergoing TAVI(with out tracheal intubation) from June 2017 to March 2019 at Sakakibara Heart Institute
Key exclusion criteria
informed consent was not obtained, emergent TAVI, ventilated, NYHA4, administerd inotropic agents, registered to other trial, difficult to undergoing respiratory function test.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuko Furuichi |
Organization
Sakakibara heart Institute
Division name
Dept of Anesthesiology
Zip code
Address
3-16-1, Asahi-cho, Fuchu-shi, Tokyo, Japan
TEL
042-314-3111
yukof@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuko Furuichi |
Organization
Sakakibara heart Institute
Division name
Dept of Anesthesiology
Zip code
Address
3-16-1, Asahi-cho, Fuchu-shi, Tokyo, Japan
TEL
042-314-3111
Homepage URL
yukof@nms.ac.jp
Sponsor or person
Institute
Sakakibara heart Institute
Institute
Department
Personal name
Funding Source
Organization
Sakakibara heart Institute
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
| 2018 | Year | 01 | Month | 21 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 06 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 21 | Day |
Last modified on
| 2018 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035301
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
