UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042434 |
|---|---|
| Receipt number | R000048442 |
| Scientific Title | Effect of preoperative physical function and cognitive function during hospitalization on total readmission for 6 months after discharge in patients with transcatheter aortic valve implantation (TAVI) |
| Date of disclosure of the study information | 2020/11/13 |
| Last modified on | 2020/11/12 20:30:07 |
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Basic information
Public title
Effect of preoperative physical function and cognitive function during hospitalization on total readmission for 6 months after discharge in patients with transcatheter aortic valve implantation (TAVI)
Acronym
Effect of physical and cognitive function on total readmission for 6 months after discharge in patients with transcatheter aortic valve implantation (TAVI)
Scientific Title
Effect of preoperative physical function and cognitive function during hospitalization on total readmission for 6 months after discharge in patients with transcatheter aortic valve implantation (TAVI)
Scientific Title:Acronym
Effect of physical and cognitive function on total readmission for 6 months after discharge in patients with transcatheter aortic valve implantation (TAVI)
Region
| Japan |
Condition
Condition
Aortic valve stenosis
Classification by specialty
| Cardiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of combined evaluation of physical function and cognitive function in TAVI patients on All readmission within 6 months
Basic objectives2
Others
Basic objectives -Others
To clarify whether it can be a predictor of All readmission
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
All readmissions
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients who received AS diagnosis and underwent TAVI
Key exclusion criteria
1.Scheduled readmission
2.Death discharge patient
3.Patients with SPPB and cognitive function unevaluated
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yuya |
| Middle name | |
| Last name | Ichinose |
Organization
Kobe City Medical Center General Hospital
Division name
Department of Rehabilitation
Zip code
650-0047
Address
2-1-1 Minatojima Minamimachi, Chuo-ku, Kobe
TEL
078-302-4321
hpm19001@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Yuya |
| Middle name | |
| Last name | Ichinose |
Organization
Kobe City Medical Center General Hospital
Division name
Department of Rehabilitation
Zip code
650-0047
Address
2-1-1 Minatojima Minamimachi, Chuo-ku, Kobe
TEL
078-302-4321
Homepage URL
hpm19001@nuhw.ac.jp
Sponsor or person
Institute
Kobe City Medical Center General Hospital
Institute
Department
Personal name
Funding Source
Organization
Kobe City Medical Center General Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe City Medical Center General Hospital
Address
2-1-1 Minatojima Minamimachi, Chuo-ku, Kobe
Tel
078-302-4321
hpm19001@nuhw.ac.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
神戸市立医療センター中央市民病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 13 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective study
Management information
Registered date
| 2020 | Year | 11 | Month | 12 | 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=R000048442
