UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046164 |
|---|---|
| Receipt number | R000052695 |
| Scientific Title | The association between intraoperative measures using transesophageal echocardiography and postoperative measures using transthoracic echocardiography |
| Date of disclosure of the study information | 2021/11/24 |
| Last modified on | 2024/09/25 16:46:49 |
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Basic information
Public title
The association between intraoperative measures using transesophageal echocardiography and postoperative measures using transthoracic echocardiography
Acronym
The association between intraoperative measures using transesophageal echocardiography and postoperative measures using transthoracic echocardiography
Scientific Title
The association between intraoperative measures using transesophageal echocardiography and postoperative measures using transthoracic echocardiography
Scientific Title:Acronym
The association between intraoperative measures using transesophageal echocardiography and postoperative measures using transthoracic echocardiography
Region
| Japan |
Condition
Condition
Patients who underwent surgical aortic valve replacement
Classification by specialty
| Cardiology | Surgery in general | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Prospectively investigate the association between intraoperative measures using TEE and postoperative measures using TTE
Basic objectives2
Others
Basic objectives -Others
Prospectively investigate the association between intraoperative measures using TEE and postoperative measures using TTE
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Peak velocity, peak pressure gradient, mean pressure gradient, effective orifice area, effective orifice area index, dimensionless index
Key secondary outcomes
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
Patients underwent surgical aortic valve replacement
Key exclusion criteria
Patient unable to give consent
Target sample size
45
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
564-8565
Address
6-1Kishibeshinmachi, Suita, Osaka
TEL
0661701070
k.minami@ncvc.go.jp
Public contact
Name of contact person
| 1st name | Kimito |
| Middle name | Minami |
| Last name | Minami |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of surgical intensive care
Zip code
564-8565
Address
6-1Kishibeshinmachi, Suita, Osaka
TEL
0661701070
Homepage URL
k.minami@ncvc.go.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
6-1Kishibeshinmachi, Suita, Osaka
Tel
0661701070
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
| 2021 | Year | 11 | Month | 24 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s11748-024-02079-x
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s11748-024-02079-x
Number of participants that the trial has enrolled
46
Results
PV, MPG, EOA, and EOAI measured intraoperatively and 1 month postoperatively were significantly correlated. The r values of each measurement were 0.35, 0.344, 0.411 and 0.323, respectively. The multivariable linear regression model showed that the multiple correlation coefficients for MG and EOA were 0.491 and 0.663, respectively.
Results date posted
| 2024 | Year | 09 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
46 patients who underwent surgical aortic valve replacement.
Participant flow
Echocardiography was performed at the following 3-time points: preoperatively, intraoperatively, and 1 month postoperatively. The correlation between intraoperative and postoperative measurement values.
Adverse events
None.
Outcome measures
peak velocity (PV), mean pressure gradient (MPG), effective orifice area (EOA), and effective orifice area index (EOAI)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 10 | Month | 20 | Day |
Other
Other related information
Prospectively investigate the association between intraoperative measures using TEE and postoperative measures using TTE at 1 week and 1 year postoperatively.
Management information
Registered date
| 2021 | Year | 11 | Month | 24 | Day |
Last modified on
| 2024 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052695
