UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014055 |
|---|---|
| Receipt number | R000016366 |
| Scientific Title | Registry of Severe Aortic Stenosis in Sendai Kousei Hospital |
| Date of disclosure of the study information | 2014/06/01 |
| Last modified on | 2014/07/03 20:45:20 |
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Basic information
Public title
Registry of Severe Aortic Stenosis in Sendai Kousei Hospital
Acronym
Registry of Severe Aortic Stenosis in Sendai Kousei Hospital
Scientific Title
Registry of Severe Aortic Stenosis in Sendai Kousei Hospital
Scientific Title:Acronym
Registry of Severe Aortic Stenosis in Sendai Kousei Hospital
Region
| Japan |
Condition
Condition
Severe aortic stenosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Observational study, registry of severe aortic stenosis in Sendai Kousei Hospital
Basic objectives2
Others
Basic objectives -Others
To enroll all patient of severe aortic stenosis in Sendai Kousei Hospital and to investigate their clinical background, outcome in interventional therapy such as surgery or transcatheter therapy, and outcome in medical therapy.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Survival at 1 year
Key secondary outcomes
30days cardiovascular death in interventional therapy cohort
30days major adverse event in interventional therapy cohort
Major adverse event at 1 year
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Severe aortic stenosis defined as maximal aortic valve velocity greater than 4.0 m/s, systolic mean gradient greater than 40mmHg, or aortic valve area 1.0cm2 in echocardiography
Key exclusion criteria
Aortic prosthetic valve
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norio Tada |
Organization
Sendai Kousei Hospital
Division name
Cardiovascular center
Zip code
Address
4-15 Hirosemachi Aoba Sendai, Miyagi
TEL
022-222-6181
noriotada@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norio Tada |
Organization
Sendai Kousei Hospital
Division name
Cardiovascular center
Zip code
Address
4-15 Hirosemachi Aoba Sendai, Miyagi
TEL
022-222-6181
Homepage URL
noriotada@hotmail.com
Sponsor or person
Institute
Sendai Kousei Hospital
Institute
Department
Personal name
Funding Source
Organization
Sendai Kousei 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
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
| 2014 | Year | 06 | Month | 01 | 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
| 2014 | Year | 05 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 05 | Month | 31 | Day |
Other
Other related information
This is an observational study.
Management information
Registered date
| 2014 | Year | 05 | Month | 24 | Day |
Last modified on
| 2014 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016366
| 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 |
