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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029393
Receipt No. R000033561
Scientific Title Okinawa Severe Aortic Stenosis Registry
Date of disclosure of the study information 2017/10/03
Last modified on 2017/10/03

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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
Email 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
Email msiwabuchi@yahoo.co.jp

Sponsor
Institute University of the Ryukyus
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033561

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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