UMIN-CTR Clinical Trial

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
Email	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
Email	hiroshi.katayama@ompu.ac.jp

Sponsor
Institute	Osaka Medical College Department of Pediatrics
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053882