UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036635 |
|---|---|
| Receipt number | R000041735 |
| Scientific Title | Non-invasive evaluation of left atrial pressure using 3-dimensional echocardiography |
| Date of disclosure of the study information | 2019/05/13 |
| Last modified on | 2019/05/01 15:23:45 |
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Basic information
Public title
Non-invasive evaluation of left atrial pressure using 3-dimensional echocardiography
Acronym
Non-invasive evaluation of left atrial pressure using 3-dimensional echocardiography
Scientific Title
Non-invasive evaluation of left atrial pressure using 3-dimensional echocardiography
Scientific Title:Acronym
Non-invasive evaluation of left atrial pressure using 3-dimensional echocardiography
Region
| Japan |
Condition
Condition
Heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to validate the left atrial pressure estimated by echocardiography with the measurements obtained by cardiac catheterization.
Basic objectives2
Others
Basic objectives -Others
Evaluation of feasibility and reproducibility
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The validity of the left atrial pressure estimated by echocardiography with the measurements obtained by cardiac catheterization
Key secondary outcomes
The comparison between the indices such as cardiac output and pulmonary arterial pressure, and echocardiographic parameters.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are scheduled for right heart catheterization for medical purposes
Key exclusion criteria
Emergency cases, hemodynamic instability, atrial fibrillation, severe mitral regurgitation, moderate or severe mitral stenosis
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Yoshizane |
Organization
Gifu Prefectural General Medical Center
Division name
Department of Cardiology
Zip code
500-8717
Address
4-6-1 Noishiki, Gifu City, Gifu, Japan
TEL
058-246-1111
takashiyoshizane@gmail.com
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Yoshizane |
Organization
Gifu Prefectural General Medical Center
Division name
Department of Cardiology
Zip code
500-8717
Address
4-6-1 Noishiki, Gifu City, Gifu, Japan
TEL
058-246-1111
Homepage URL
takashiyoshizane@gmail.com
Sponsor or person
Institute
Gifu Prefectural General Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
Gifu Prefectural general Medical Center Ethics Committee
Address
4-6-1 Noishiki, Gifu City, Gifu, Japan
Tel
058-246-1111
takashiyoshizane@gmail.com
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
| 2019 | Year | 05 | Month | 13 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 03 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Echocardiography was performed just before the catheterization and we analyzed the data by off-line 3D speckle tracking software.
Management information
Registered date
| 2019 | Year | 05 | Month | 01 | Day |
Last modified on
| 2019 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041735
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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