UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034737 |
|---|---|
| Receipt number | R000039547 |
| Scientific Title | Thermodilution vs arterial pressure-based cardiac output measurement in the transcatheter aortic valve implantation |
| Date of disclosure of the study information | 2018/11/30 |
| Last modified on | 2022/11/04 09:49:54 |
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Basic information
Public title
Thermodilution vs arterial pressure-based cardiac output measurement in the transcatheter aortic valve implantation
Acronym
Thermodilution vs arterial pressure-based cardiac output measurement in the transcatheter aortic valve implantation
Scientific Title
Thermodilution vs arterial pressure-based cardiac output measurement in the transcatheter aortic valve implantation
Scientific Title:Acronym
Thermodilution vs arterial pressure-based cardiac output measurement in the transcatheter aortic valve implantation
Region
| Japan |
Condition
Condition
Aortic stenosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify which is better to measure cardiac output, thermodilution or arterial pressure-based method in the trans-catheter aortic valve implantation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
changes of cardiac output to dobutamine infusion
Key secondary outcomes
changes of cardiac output after the aortic valve implantation
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
| 70 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients who undergoing transcatheter aortic-valve implantation
Key exclusion criteria
patients who need extra-corporeal membrane oxygenation for cardiac colapse
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ayumi Kunitake |
Organization
Miyazaki Medical Association Hospital
Division name
Department of Anesthesiology
Zip code
Address
738-1 funato shin-beppu Miyazaki, Miyazaki, Japan
TEL
0985249119
ayumi.kunitake@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ayumi Kunitake |
Organization
Miyazaki Medical Association Hospital
Division name
Department of Anesthesiology
Zip code
Address
738-1 funato shin-bepp, Miyazaki, Miyazaki, Japan
TEL
0985249119
Homepage URL
ayumi.kunitake@gmail.com
Sponsor or person
Institute
Miyazaki Association Hospital
Institute
Department
Personal name
Funding Source
Organization
Miyazaki Association Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2018 | Year | 11 | Month | 30 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2020 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2020 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 09 | Month | 01 | Day |
Other
Other related information
changes of cardiac output on dobutamine infusion and aortic-valve implantation
Management information
Registered date
| 2018 | Year | 11 | Month | 01 | Day |
Last modified on
| 2022 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039547
