UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061008 |
|---|---|
| Receipt number | R000069812 |
| Scientific Title | Utility of right ventricular myocardial performance index measured by intraoperative transesophageal echocardiography for assessing right ventricular function during cardiac surgery |
| Date of disclosure of the study information | 2026/03/23 |
| Last modified on | 2026/03/22 11:16:18 |
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Basic information
Public title
Utility of right ventricular myocardial performance index (RVMPI) measured by intraoperative transesophageal echocardiography for assessing right ventricular function during cardiac surgery
Acronym
TEE-RVMPI study
Scientific Title
Utility of right ventricular myocardial performance index measured by intraoperative transesophageal echocardiography for assessing right ventricular function during cardiac surgery
Scientific Title:Acronym
Utility of RVMPI measured by transesophageal echocardiography for assessing right ventricular function
Region
| Japan |
Condition
Condition
Patients planned for cardiac surgery with cardiopulmonary bypass
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the impact of intraoperative RVMPI, measured in patients undergoing cardiac surgery with cardiopulmonary bypass, on postoperative outcomes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between RVMPI measured at the end of cardiac surgery and the occurrence of major postoperative complications
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 planned for cardiac surgery with cardiopulmonary bypass at Osaka Metropolitan University Hospital
Key exclusion criteria
1. Contraindication to transesophageal echocardiography (TEE)
2. Contraindication to any of the planned anesthetic agents (propofol, fentanyl, remifentanil, or rocuronium)
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Hori |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
545-8586
Address
1-5-7 Asahimachi, Abenoku, Osaka
TEL
06-6645-2121
k.hori@omu.ac.jp
Public contact
Name of contact person
| 1st name | kotaro |
| Middle name | |
| Last name | Hori |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
545-8586
Address
1-5-7 Asahimachi, Abenoku, Osaka
TEL
06-6645-2121
Homepage URL
k.hori@omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Osaka Metropolitan University
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Office for Research Promotion, Abeno Campus Administrative Office, Osaka Metropolitan University
Address
6th Floor, Abeno Medix, 1-2-7 Asahimachi, Abenoku, Osaka
Tel
06-6645-3456
gr-a-knky-ethics@omu.ac.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
| 2026 | Year | 03 | Month | 23 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study aims to evaluate the impact of intraoperative RVMPI, measured in patients undergoing cardiac surgery with cardiopulmonary bypass, on postoperative outcomes. Furthermore, by comparing RVMPI with other echocardiographic parameters such as RVFAC and LVMPI, this study seeks to clarify its role as an index of right ventricular function in cardiac surgery and to evaluate its relationship with left ventricular function.
Management information
Registered date
| 2026 | Year | 03 | Month | 22 | Day |
Last modified on
| 2026 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069812
