UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032085 |
|---|---|
| Receipt number | R000036603 |
| Scientific Title | A retrospective observational study investigating the change of transvalvular peak velocity among patients undergoing aortic valve replacement with bioprosthetic valve. |
| Date of disclosure of the study information | 2018/05/01 |
| Last modified on | 2021/06/04 21:12:56 |
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Basic information
Public title
A retrospective observational study investigating the change of transvalvular peak velocity among patients undergoing aortic valve replacement with bioprosthetic valve.
Acronym
AVR TEE study
Scientific Title
A retrospective observational study investigating the change of transvalvular peak velocity among patients undergoing aortic valve replacement with bioprosthetic valve.
Scientific Title:Acronym
AVR TEE study
Region
| Japan |
Condition
Condition
Patients undergoing aortic valve replacement with bioprosthetic valve.
Classification by specialty
| Cardiology | Surgery in general | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Aortic valve replacement (AVR) is an established procedure for treating aortic valvular diseases. Prosthesis-patient mismatch(PPM)is known as the factor increasing the postoperative mortality and morbidity. If intraoperative measurement of transvalvular peak velocity could predict postoperative PPM, intraoperative diagnosis and additional intervention may prevent postoperative PPM.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The interactions between time series variation of an adjusted peak trans-prosthetic valvular velocity and an intraoperative peak trans-prosthetic valvular velocity.
Key secondary outcomes
The interaction between time series variation of an adjusted peak trans-prosthetic valvular velocity and an implanted bio-prosthetic valve size, or a type of the implanted bio-prosthetic valve.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient undergoing aortic valve replacement with bioprosthetic valve.
Key exclusion criteria
none
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Kimito |
| Middle name | |
| Last name | Minami |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Surgical Intensive Care
Zip code
565-8565
Address
5-7-1 Fujishirodai, Suita, Osaka, Japan
TEL
06-6833-5012
nann_5115@ybb.ne.jp
Public contact
Name of contact person
| 1st name | Kimito |
| Middle name | |
| Last name | Minami |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Surgical Intensive Care
Zip code
565-8565
Address
5-7-1 Fujishirodai, Suita, Osaka, Japan
TEL
06-6833-5012
Homepage URL
nann_5115@ybb.ne.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
National Cerebral and Cardiovascular Center
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
National Cerebral and Cardiovascular Center
Address
5-7-1 Fujishirodai, Suita, Osaka, Japan
Tel
06-6833-5012
k.minami@ncvc.go.jp
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 | 05 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.jcvaonline.com/article/S1053-0770(19)30512-9/fulltext
Publication of results
Published
Result
URL related to results and publications
https://www.jcvaonline.com/article/S1053-0770(19)30512-9/fulltext
Number of participants that the trial has enrolled
556
Results
A multivariable logistic regression model was used to identify the predictors of patient-prosthesis mismatch at 1 year. There was no significant association between intraoperative peak velocity and peak velocity at 1 month (p = 0.419) or 1 year (p = 0.115). The implanted valve type (p < 0.001) and size (p < 0.001), but not intraoperative peak velocity (p = 0.503), were independent predictors of patient-prosthesis mismatch.
Results date posted
| 2019 | Year | 10 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study comprised 556 patients who underwent aortic valve replacement with a bioprosthetic valve.
Participant flow
Retrospectively reviewed from clinical record.
Adverse events
None.
Outcome measures
The associations between peak velocity values at the aforementioned 3 time points were analyzed using a multivariable nonlinear regression model. A multivariable logistic regression model was used to identify the predictors of patient-prosthesis mismatch at 1 year.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 04 | Month | 03 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 28 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 28 | Day |
Date of closure to data entry
| 2018 | Year | 05 | Month | 28 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 28 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Intraoperative trans-prosthetic valvular peak velocity, postoperative trans-prosthetic valvular peak velocity were extracted from medical record. Trans-prosthetic valvular peak velocity were adjusted for age, sex, body surface area, size of implanted bio-prosthetic valve, type of implanted bio-prosthetic valve, presence or absence of aortic insufficiency, morphology of aortic valve (tricuspid or bicuspid valve), and preoperative stroke volume. The interaction between time-series variation of peak trans-prosthetic valvular velocity and intraoperative peak trans-prosthetic valvular velocity was assessed using a linear regression model adjusted by the Huber-White method for repeated measures data.
Management information
Registered date
| 2018 | Year | 04 | Month | 03 | Day |
Last modified on
| 2021 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036603
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