UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022704 |
|---|---|
| Receipt number | R000026163 |
| Scientific Title | Volume-outcome relationships in surgical aortic valve replacement and transcatheter aortic valve implantation in aortic valve stenosis |
| Date of disclosure of the study information | 2016/06/12 |
| Last modified on | 2019/02/10 14:54:10 |
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Basic information
Public title
Volume-outcome relationships in surgical aortic valve replacement and transcatheter aortic valve implantation in aortic valve stenosis
Acronym
Volume-outcome relationships in surgical aortic valve replacement and transcatheter aortic valve implantation
Scientific Title
Volume-outcome relationships in surgical aortic valve replacement and transcatheter aortic valve implantation in aortic valve stenosis
Scientific Title:Acronym
Volume-outcome relationships in surgical aortic valve replacement and transcatheter aortic valve implantation
Region
| Japan |
Condition
Condition
aortic valve stenosis
Classification by specialty
| Anesthesiology | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate association between surgical aortic valve replacement volume and outcomes, and transcatheter aortic valve implantation volume and outcomes.
Basic objectives2
Others
Basic objectives -Others
epidemiology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Hospital mortality
Key secondary outcomes
28 day mortality
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
adult patients who had aortic valve replacement or transcatheter aortic valve implantation for aortic valve stenosis from April 1, 2012 to March 31, 2016
Key exclusion criteria
under 20 years of age at admission
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Umegaki |
Organization
Kansai Medical University Hospital
Division name
Department of Anesthesiology
Zip code
Address
Department of Anesthesiology, Kansai Medical University Hirakata Hospital, 2-3-1 Shin-machi, Hirakata, Osaka 573-1191, Japan
TEL
072-804-0100(56372)
umegakit@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Umegaki |
Organization
Kansai Medical University Hospital
Division name
Department of Anesthesiology
Zip code
Address
Department of Anesthesiology, Kansai Medical University Hospital, 2-3-1 Shin-machi, Hirakata city
TEL
072-804-0100(56372)
Homepage URL
http://www7.kmu.ac.jp/anesthw/AS.html
umegakit@hirakata.kmu.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Kansai Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Healthcare Economics and Quality Management, Kyoto University Graduate School of Medicine
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
| 2016 | Year | 06 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.imedpub.com/heart-and-cardiovascular-research/
Number of participants that the trial has enrolled
Results
This study aimed to assess between isolated surgical aortic valve replacement (SAVR) and mortality in patients with aortic valve stenosis using a large-scale study conducted in Japan. Higher hospital volume was significantly associated with reduced mortality, and patients with aortic valve stenosis may benefit from care in high-volume hospitals.
Results: The low-volume group, intermediate-volume group, and high-volume group comprised 7383 patients from 330 hospitals, 5253 patients from 76 hospitals, and 3411 patients from 23 hospitals, respectively. The regression analysis accounted for patient sex, height, weight, activities of daily living, and comorbidities as covariates. Relative to the intermediate-volume group, the odds ratios for in-hospital mortality were 1.32 (95% confidence intervals: 1.07-1.61; P<0.01) in the low-volume group and 0.65 (0.48-0.87; P<0.01) in the high-volume group.
Conclusion: Higher hospital volume was significantly associated with reduced mortality, and patients with aortic valve stenosis may benefit from care in high-volume hospitals.
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
| 2010 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | 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
retrospective cohort study
Management information
Registered date
| 2016 | Year | 06 | Month | 12 | Day |
Last modified on
| 2019 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026163
