UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062042 |
|---|---|
| Receipt number | R000068475 |
| Scientific Title | Evaluation of Pulmonary Vascular Structure and Clinical Significance in Obstructive Lung Disease Using Imaging and Biomarkers |
| Date of disclosure of the study information | 2026/06/24 |
| Last modified on | 2026/06/24 13:46:03 |
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Basic information
Public title
Study on the Relationship Between Pulmonary Vascular Structure and Pathophysiology Using CT Imaging and Biomarkers
Acronym
PVCI Study
Scientific Title
Evaluation of Pulmonary Vascular Structure and Clinical Significance in Obstructive Lung Disease Using Imaging and Biomarkers
Scientific Title:Acronym
PVCI-OLD Study
Region
| Japan |
Condition
Condition
Chronic Obstructive Pulmonary Disease (COPD), Non-COPD respiratory diseases including bronchial asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to clarify the relationship between pulmonary vascular structural abnormalities (particularly vascular pruning) and decreased physical activity in obstructive lung diseases, and to examine the validity and disease specificity of this relationship. By including healthy controls, chronic obstructive pulmonary disease (COPD) patients, and non-COPD respiratory disease patients as comparators, we aim to explore the potential for new assessment indices and stratification methods based on pulmonary vascular structural abnormalities. Furthermore, through integrated analysis of imaging assessments (brain MRI, chest CT) and blood biomarkers (exosome-derived molecules, GDF-15, etc.), we aim to capture the neural basis of decreased physical activity and the overall pathophysiology, striving for precise understanding of obstructive lung diseases and application to personalized medicine.
Basic objectives2
Others
Basic objectives -Others
Elucidation of the relationship between disease specificity and prognosis in obstructive lung diseases through integrated analysis of imaging assessments (pulmonary vascular structure, mucus plugs, brain structure) and biomarkers (exosome-derived molecules, GDF-15, etc.)
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Association between pulmonary vascular structure indices extracted from chest CT images (vascular pruning index, TBV5, etc.) and physical activity indices evaluated by accelerometer (daily step count, exercise intensity, activity time, etc.) (analysis using data collected in previous studies)
Key secondary outcomes
1) Association between mucus plug indices evaluated from chest CT images (mucus plug score, distribution pattern, occupancy area, etc.) and physical activity indices
2) Association between structural and functional markers extracted from brain MRI (cortical thickness, hippocampal volume, FA, cerebral blood flow, etc.) and physical activity indices
3) Association between blood biomarkers (GDF-15, exosome-derived microRNA, proteins, etc.) and pulmonary vascular structure indices, physical activity indices
4) Comparison of pulmonary vascular structural abnormalities among disease groups (COPD patients, non-COPD respiratory disease patients) and healthy controls
5) Association between pulmonary vascular structure indices, mucus plug indices and clinical indicators (pulmonary function, inflammatory markers, etc.)
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Gender: Both males and females
2) Age 40 years or older at the time of consent
3) Smoking history: Not specified (H28-031 included current smokers or those with smoking history as criteria, while H27-204 did not set criteria regarding smoking history; therefore, this study does not specify smoking history)
4) Participants who enrolled in either of the previous studies (H27-204, H28-031) with documented informed consent obtained voluntarily and not subsequently withdrawn
Key exclusion criteria
Among healthy controls, those who did not undergo chest CT imaging for diagnostic purposes in routine clinical practice
Target sample size
129
Research contact person
Name of lead principal investigator
| 1st name | Tsunahiko |
| Middle name | |
| Last name | Hirano |
Organization
Yamaguchi University Hospital
Division name
Department of Respiratory Medicine and Infectious Diseases
Zip code
755-8505
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan
TEL
0836-85-3123
tsuna@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Tsunahiko |
| Middle name | |
| Last name | Hirano |
Organization
Yamaguchi University Hospital
Division name
Department of Respiratory Medicine and Infectious Diseases
Zip code
755-8505
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi
TEL
0836853123
Homepage URL
tsuna@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University Hospital
Institute
Department
Personal name
Tsunahiko Hirano
Funding Source
Organization
Others
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamaguchi University Hospital
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan
Tel
0836-85-3123
tsuna@yamaguchi-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
山口大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 24 | 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
129
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
| 2026 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an observational study evaluating pulmonary vascular structures using CT imaging and biomarkers in patients with obstructive pulmonary disease. No intervention will be performed. Existing clinical data will be collected and analyzed.
Management information
Registered date
| 2026 | Year | 06 | Month | 24 | Day |
Last modified on
| 2026 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068475
