UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060169 |
|---|---|
| Receipt number | R000068800 |
| Scientific Title | Non-invasive Assessment of Pulmonary Circulation using Deep Learning on dynamic chest radiography |
| Date of disclosure of the study information | 2025/12/22 |
| Last modified on | 2025/12/22 23:00:44 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Non-invasive Assessment of Pulmonary Circulation using Deep Learning on dynamic chest radiography
Acronym
Lung Circulation Imaging using Deep Learning study
Scientific Title
Non-invasive Assessment of Pulmonary Circulation using Deep Learning on dynamic chest radiography
Scientific Title:Acronym
Non-invasive Assessment of Pulmonary Circulation using Deep Learning on dynamic chest radiography
Region
| Japan |
Condition
Condition
Pulmonary vascular diseases
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to develop a deep learning based artificial intelligence model that enables minimally invasive and quantitative prediction of pulmonary circulatory hemodynamics using pulmonary circulation images derived from X ray fluoroscopic videos.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To assess the agreement between mean pulmonary arterial pressure (mPAP) predicted by a deep learning model using pulmonary circulation images and measured mPAP obtained by right heart catheterization.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 years or older who underwent right heart catheterization.
Key exclusion criteria
Pregnant women or women who may be pregnant.
Patients in whom acquisition of dynamic images is difficult due to inability to maintain a relatively regular cardiac rhythm, such as atrial fibrillation.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Kaoru |
| Middle name | |
| Last name | Dohi |
Organization
Mie University Graduate School of Medicine
Division name
Department of Cardiology and Nephrology
Zip code
514-8507
Address
2-174 Edobashi, Tsu, Japan
TEL
+81-59-231-5015
dohik@med.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshito |
| Middle name | |
| Last name | Ogihara |
Organization
Mie University Graduate School of Medicine
Division name
Department of Heath Care Transition
Zip code
514-8507
Address
2-174 Edobashi, Tsu, Japan
TEL
+81-59-231-5015
Homepage URL
yoshito@med.mie-u.ac.jp
Sponsor or person
Institute
Mie University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Institutional Review Board, Mie University Hospital
Address
2-174, Edobashi, Tsu, Mie
Tel
+81-59-231-5045
kk-sien@med.mie-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
| 2025 | Year | 12 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 12 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 24 | Day |
Last follow-up date
| 2035 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 12 | Month | 22 | Day |
Last modified on
| 2025 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068800
