UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051863 |
|---|---|
| Receipt number | R000059176 |
| Scientific Title | Verification of reliability of esCCO system in TAVI |
| Date of disclosure of the study information | 2023/08/09 |
| Last modified on | 2024/04/10 10:47:06 |
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Basic information
Public title
Verification of reliability of esCCO system in TAVI
Acronym
Verification of reliability of esCCO system in TAVI
Scientific Title
Verification of reliability of esCCO system in TAVI
Scientific Title:Acronym
Verification of reliability of esCCO system in TAVI
Region
| Japan |
Condition
Condition
aortic stenosis, aortic regurgitation
Classification by specialty
| Cardiology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of followability of esCCO system and FloTrac system to cardiac output measured using pulmonary artery catheter(ICO) in TAVI
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of esCCO/ICO ratio and FloTrac CCO/ICO ratio before and after TAVI
Key secondary outcomes
Correlation coefficient between esCCO and ICO before and after TAVI
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
Adult patients undergoing TAVI at our hospital who have given written informed consent to participate in the study
Key exclusion criteria
none
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Noboru |
| Middle name | |
| Last name | Saeki |
Organization
Division of Clinical Medical Science, Graduate School of Biomedical Sciences, Hiroshima University
Division name
Department of Anesthesiology and Critical Care
Zip code
734-8551
Address
1-2-3,Kasumi,Minami-ku,Hiroshima
TEL
81-082-327-5267
nsaeki@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Daiki |
| Middle name | |
| Last name | Shorin |
Organization
Division of Clinical Medical Science, Graduate School of Biomedical Sciences, Hiroshima University
Division name
Department of Anesthesiology and Critical Care
Zip code
734-8551
Address
1-2-3,Kasumi,Minami-ku,Hiroshima
TEL
81-082-256-5267
Homepage URL
daikishorin@gmail.com
Sponsor or person
Institute
Department of Anesthesiology and Critical Care, Division of Clinical Medical Science, Graduate School of Biomedical Sciences, Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Hiroshima University
Address
1-2-3,Kasumi,Minami-ku,Hiroshima
Tel
81-082-257-5907
iryo-seisaku@office.hiroshima-u.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
| 2023 | Year | 08 | Month | 09 | 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
10
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
| 2022 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Compare the esCCO/ICO ratio and FloTrac CCO/ICO ratio before and after TAVI to evaluate followability
Management information
Registered date
| 2023 | Year | 08 | Month | 08 | Day |
Last modified on
| 2024 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059176
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
