UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034169 |
|---|---|
| Receipt number | R000038891 |
| Scientific Title | Contemporary outcomes after surgery and medical treatment in patients with severe aortic stenosis registry-2 |
| Date of disclosure of the study information | 2018/09/16 |
| Last modified on | 2021/03/29 00:13:36 |
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Basic information
Public title
Contemporary outcomes after surgery and medical treatment in patients with severe aortic stenosis registry-2
Acronym
CURRENT AS Registry-2
Scientific Title
Contemporary outcomes after surgery and medical treatment in patients with severe aortic stenosis registry-2
Scientific Title:Acronym
CURRENT AS Registry-2
Region
| Japan |
Condition
Condition
Aortic stenosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the clinical outcomes after introduction of transcatheter aortic valve implantation. We have some consensus about the management of patients with severe AS, based on findings from CURRENT AS Registry cohort 1, and evaluate clinical outcomes of patients in cohort 2 as compared with those in cohort 1.
Basic objectives2
Others
Basic objectives -Others
To reveal clinical outcomes.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A composite of aortic valve-related death and heart failure hospitalization
Key secondary outcomes
all cause death, cardiovascular death, noncardiovascular death, aortic valve related death, heart failure hospitalization, sudden death, stroke, life threatening/disabling bleeding, emerging symptoms related to AS
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 who are diagnosed as severe aortic valve stenosis (aortic valve area less than 1.0cm2, mean gradient greater than 40 mm Hg, or aortic jet velocity greater than 4.0 m/s) from 2018 to 2023 by transthoracic echocardiography.
Key exclusion criteria
Prosthetic valve stenosis
History of percutaneous balloon aortic valvuloplasty
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Kimura |
Organization
Kyoto University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
54 Shogoin-kawaramachi, sakyo-ku, kyoto 606-8507 JAPAN
TEL
075-751-4255
taketaka@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiko Taniguchi, Yasuaki Takeji |
Organization
Kyoto University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
54 Shogoin-kawaramachi, sakyo-ku, kyoto 606-8507 JAPAN
TEL
075-751-4255
Homepage URL
ytakeji@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kyoto University 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
| 2018 | Year | 09 | Month | 16 | 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
3000
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 04 | Month | 16 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 16 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
CURRENT AS Registry-2 is a multicenter, prospective registry enrolling consecutive patients with severe AS between 2018 and 2023.
Management information
Registered date
| 2018 | Year | 09 | Month | 16 | Day |
Last modified on
| 2021 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038891
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
