UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041672 |
|---|---|
| Receipt number | R000047565 |
| Scientific Title | Analysis a relationship between pulmonary artery pressure and surrogate parameters, and the diagnostic accuracy |
| Date of disclosure of the study information | 2020/09/04 |
| Last modified on | 2020/09/03 16:07:11 |
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Basic information
Public title
Exploratory Study for Investigating Surrogate Markers of Pulmonary Artery Pressure and Other Hemodynamic Metrics
Acronym
E-SAP
Scientific Title
Analysis a relationship between pulmonary artery pressure and surrogate parameters, and the diagnostic accuracy
Scientific Title:Acronym
E-SAP
Region
| Japan |
Condition
Condition
cardiovascular disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines the relationship between measurement parameter of right heart catheterization and heart sounds, and to investigate the diagnostic accuracy to different phenotypes of pulmonary hypertension.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between measurement parameter of right heart catheterization and heart sounds (CABs)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Adult patients referred for right heart catheterization
2) Intensive care unit in-patients with a Swan-Ganz pulmonary artery catheter inserted
Key exclusion criteria
1) Patients who are unable to give consent will be excluded in the absence of a guardian with a durable power of attorney to give consent on her/his behalf.
2) ICU in-patients with a Swan-Ganz catheter inserted in them who are hemodynamically unstable
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ko-ichi |
| Middle name | |
| Last name | Node |
Organization
Saga University
Division name
Department of Cardiovascular Medicine
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga, Japan
TEL
0952-34-2364
cardiostudy@ml.cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Norihiko |
| Middle name | |
| Last name | Kotooka |
Organization
Saga University
Division name
Department of Cardiovascular Medicine
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga, Japan
TEL
0952-34-2364
Homepage URL
kotooka@cc.saga-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Saga University
Institute
Department
Personal name
Funding Source
Organization
Asahi Kasei Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Center,Saga University Hospital
Address
5-1-1 Nabeshima, Saga
Tel
0952-34-3400
kenkyu-shinsei@ml.cc.saga-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
| 2020 | Year | 09 | Month | 04 | 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
40
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
| 2019 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 13 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective analysis of a relationship between pulmonary artery pressure and cardiac acoustic parameters.
Management information
Registered date
| 2020 | Year | 09 | Month | 03 | Day |
Last modified on
| 2020 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047565
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
