UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032353 |
|---|---|
| Receipt number | R000036901 |
| Scientific Title | A prospective registry of physical and psychological functional status after surgical or transcatheter aortic valve replacement in patients with aortic valve stenosis. |
| Date of disclosure of the study information | 2018/04/24 |
| Last modified on | 2023/06/20 19:02:35 |
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Basic information
Public title
A prospective registry of physical and psychological functional status after surgical or transcatheter aortic valve replacement in patients with aortic valve stenosis.
Acronym
Registry of physical and psychological functional status after SAVR or TAVI.
Scientific Title
A prospective registry of physical and psychological functional status after surgical or transcatheter aortic valve replacement in patients with aortic valve stenosis.
Scientific Title:Acronym
Registry of physical and psychological functional status after SAVR or 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 investigate physical and psychological functional status at before and after SAVR or TAVI, and to find out which pre procedural markers predict these recovery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Ambulation status at a week, 1, 6 and 12 months after procedure. Ambulation status is evaluated with 6-min walk test.
Key secondary outcomes
Cumulative survival rate after procedure.
Re-admission after procedure.
Physical function at a week, 1, 6 and 12 months after procedure.
Mini-mental state examination at a week, 1, 6 and 12 months after procedure.
SF-12 at 1, 6 and 12 months after procedure.
NYHA classification at a week, 1, 6 and 12 months after procedure.
Katz index of ADL at a week, 1, 6 and 12 months after procedure.
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Age 75 years or older, undergoing TAVI or SAVR with or without concomitant revascularization at Tokushima Red Cross Hospital.
Key exclusion criteria
Need for emergency surgery, clinical instability, concomitant replacement or repair of another heart valve or the aorta, difficult to undergoing physical or psychological function test, informed consent was not obtained.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Takase |
Organization
Tokushima Red Cross Hospital
Division name
Department of Rehabilitation
Zip code
Address
Irinokuchi 103-banchi, Komatsushima Town, Komatsushima City, Tokushima Pref, 773-8502, Japan.
TEL
0885-32-2555
mk_koudai@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Takase |
Organization
Tokushima Red Cross Hospital
Division name
Department of Rehabilitation
Zip code
Address
Irinokuchi 103-banchi, Komatsushima Town, Komatsushima City, Tokushima Pref, 773-8502, Japan.
TEL
0885-32-2555
Homepage URL
mk_koudai@yahoo.co.jp
Sponsor or person
Institute
Tokushima Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
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
徳島赤十字病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 24 | 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
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 21 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective, observational study.
Management information
Registered date
| 2018 | Year | 04 | Month | 24 | Day |
Last modified on
| 2023 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036901
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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