UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029393 |
|---|---|
| Receipt number | R000033561 |
| Scientific Title | Okinawa Severe Aortic Stenosis Registry |
| Date of disclosure of the study information | 2017/10/03 |
| Last modified on | 2017/10/03 00:44:38 |
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Basic information
Public title
Okinawa Severe Aortic Stenosis Registry
Acronym
Okinawa Severe Aortic Stenosis Registry
Scientific Title
Okinawa Severe Aortic Stenosis Registry
Scientific Title:Acronym
Okinawa Severe Aortic Stenosis Registry
Region
| Japan |
Condition
Condition
Aortic stenosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Elderly people in Okinawa have longevity. The arteriosclerotic severe aortic stenosis, which is often found in the elderly increases gradually. The elderly people have high frailty due to the complicated diseases other than valvular disease. The many cases of high-risk and inoperable cases of aortic valve replacement surgery. The new methods of treatment for such cases developed. We will assess the effectiveness of each treatment method.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary events after participation: All cause of death, sudden death cardiac death, surgical aortic valve replacement, transcatheter aortic valve replacement, balloon aortic valvuloplasty, admission by heart failure and any other reasons.
Key secondary outcomes
The echocardiographic findings, subjective complaint and blood test findings in every half years after participation.
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 with severe aortic stenosis diagnosed at Okinawa main hospital
Key exclusion criteria
None
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashi Iwabuchi |
Organization
Graduate School of Medicine, University of the Ryukyus
Division name
Department of Cardiovascular Medicine, Nephrology and Neurology
Zip code
Address
207 Uehara, Nihihara-cho, Okinawa, Japan
TEL
098-895-1150
msiwabuchi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masashi Iwabuchi |
Organization
Graduate School of Medicine, University of the Ryukyus
Division name
Department of Cardiovascular Medicine, Nephrology and Neurology
Zip code
Address
207 Uehara, Nihihara-cho, Okinawa, Japan
TEL
098-895-1150
Homepage URL
msiwabuchi@yahoo.co.jp
Sponsor or person
Institute
University of the Ryukyus
Institute
Department
Personal name
Funding Source
Organization
University of the Ryukyus
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
| 2017 | Year | 10 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 12 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation items: Echocardiographic findings every six months since registration, general blood tests, BNP or ProBNP and subjective symptoms, Frailty related items were registered until 3 years after registration.
Survey until 3 years after registering existence of major events. (Major events: All cause of death, sudden death, cardiac death, surgical aortic valve replacement, transcatheter aortic valve replacement, aortic valve balloon valvuloplasty, hospitalization due to heart failure, hospitalization for any reason)
Management information
Registered date
| 2017 | Year | 10 | Month | 03 | Day |
Last modified on
| 2017 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033561
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
