UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047244 |
|---|---|
| Receipt number | R000053882 |
| Scientific Title | A new approach of evaluation for pulmonary circulation -non-invasive evaluation for pulmonary vascular obstruction using by wave motion analysis - |
| Date of disclosure of the study information | 2022/03/22 |
| Last modified on | 2022/03/22 12:26:30 |
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Basic information
Public title
A new approach of evaluation for pulmonary circulation -non-invasive evaluation for pulmonary vascular obstruction using by wave motion analysis -
Acronym
A new approach of non-invasive evaluation for pulmonary vascular obstruction using by wave motion analysis
Scientific Title
A new approach of evaluation for pulmonary circulation -non-invasive evaluation for pulmonary vascular obstruction using by wave motion analysis -
Scientific Title:Acronym
A new approach of non-invasive evaluation for pulmonary vascular obstruction using by wave motion analysis
Region
| Japan |
Condition
Condition
Pediatric pulmonary hypertension
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a new diagnostic method to evaluate the degree of obstructive lesion in pulmonary vasculature noninvasively using by phase difference between vascular diameter and blood flow velocity in an internal wave motion phenomenon.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Phase angle from vascular diameter-blood velocity relation calculated by ultrasonic equipment
Phase angle from pressure -blood flow velocity relation
Key secondary outcomes
Pulmonary artery pressure
Pulmonary vascular resistance
Pulmonary/systemic blood flow ratio
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
| 1 | months-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Pediatric patients with various obstructive condition in pulmonary vasculature with oral and written informed consent
Key exclusion criteria
Cases who have significant pulmonary stenosis
Cases who are considered inappropriate for this study by the principal investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Katayama |
Organization
Osaka Medical College
Division name
Department of Pediatrics
Zip code
569-8686
Address
2-7, Daigaku-machi, Takatsuki, Osaka, Japan
TEL
072-683-1221
hiroshi.katayama@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Katayama |
Organization
Osaka Medical College
Division name
Department of Pediatrics
Zip code
569-8686
Address
2-7, Daigaku-machi, Takatsuki, Osaka, Japan
TEL
072-683-1221
Homepage URL
hiroshi.katayama@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical College
Department of Pediatrics
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kansai University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
research ethics committee, Osaka Medical College
Address
2-7, Daigaku-machi, Takatsuki, Osaka, Japan
Tel
072-683-1221
rinri@ompu.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
大阪医科大学病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 22 | 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
| 2017 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Temporal change curve on internal diameter of the main pulmonary artery will be obtained using by speckle tracking.
Flow profile will be also obtained by pulsed Doppler in the main pulmonary artery. Phase difference angle theta will be calculated from those data.
The phase angle theta will be compared with the phase angle calculated from the data of blood pressure and blood velocity obtained by cardiac catheterization.
These data will be compared with conventional parameters such as pulmonary artery pressure, pulmonary resistance and pulmonary/systemic blood flow ratio.
Management information
Registered date
| 2022 | Year | 03 | Month | 22 | Day |
Last modified on
| 2022 | 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=R000053882
