UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030821 |
|---|---|
| Receipt number | R000034956 |
| Scientific Title | Quantitative assessment of pulmonary blood flow in control subjects, subjects with chronic obstructive lung disease (COPD), or with pulmonary hypertension (PH) by 15O-H2O PET/CT |
| Date of disclosure of the study information | 2018/01/19 |
| Last modified on | 2019/07/25 12:12:43 |
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Basic information
Public title
Quantitative assessment of pulmonary blood flow in control subjects, subjects with chronic obstructive lung disease (COPD), or with pulmonary hypertension (PH) by 15O-H2O PET/CT
Acronym
Quantitative assessment of pulmonary blood flow by 15O-H2O PET/CT
Scientific Title
Quantitative assessment of pulmonary blood flow in control subjects, subjects with chronic obstructive lung disease (COPD), or with pulmonary hypertension (PH) by 15O-H2O PET/CT
Scientific Title:Acronym
Quantitative assessment of pulmonary blood flow by 15O-H2O PET/CT
Region
| Japan |
Condition
Condition
COPD, PH
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1.To assess and compare the pulmonary or myocardial blood flow and their heterogeneity of those flow in control subjects, patients with COPD, and in patients with PH.2.To compare the pulmonary blood flow assessed by 15O-H2O PET/CT and the diffusion capacity of carbon monoxide or transfer coefficient of the lung.in control subjects, patients with COPD, or with PH.Also in patient with PH, to compare the pulmonary blood flow assessed by 15O-H2O PET/CT and parameters of right heart catheterization, cardiac MRI,and Tc-MAA perfusion scintigraphy.3.To examine the pulmonary and myocardial flow reserve of blood flow in control subjects, patients with COPD, and patients with PH.4. To compare the pulmonary blood flow assessed by 15O-H2O PET/CT and the results of pulmonary function tests and scores of COPD activity test in patients with COPD. Particularly, to examine the relationships between quantity of the pulmonary blood flow assessed by 15O-H2O PET/CT and the severity of emphysema assessed by CT.
Basic objectives2
Others
Basic objectives -Others
Quantitative assessment of pulmonary blood flow by 15O-H2O PET/CT
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Pulmonary blood flow corrected by lung volume
Key secondary outcomes
Heterogeniety of pulmonary blood flow Flow reserve of pulmonary blood flow Myocardial blood flow at rest and during exercise Lung attenuation volume pulmonary function test:FEV1,FEV1FVC,DLco,DLcoVA COPD assessment test scoreEchocardiography: LV/LA diameter/area/volume,EF,cardiac output, cardiac index,LV eccentricity index, tricuspid regurgitation velocity, tricuspid annulus movement distance, Tei index, IVC diameter cardio pulmonary exercise test peak VO2, AT, VE/VCO2, stress level at AT, HR, RER, VE, VD/VT cardiac MRI: LV/RV/LA/RA volume/index, cardiac output/index, stroke volume, ventricular wall thickness/volume/index, Pulmonary circulation time, existence and volume of late enhancementRight heart catheterization: pulmonary arterial pressure, pulmonary arterial wedge pressure, RV/RA pressure, CO,CI, PVR, venous oxygen saturation ,Qr/Qs Tc-MAA perfusion scintigraphy defect of perfusion in the lung, ventilation and perfusion mismatch, the ratio of the right lung perfusion to the left lung perfusion, shunt ratio
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
15O-H2O PET/CT
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
Control subjects:Subjects without any respiratory or cardiac or other disorders that might affect pulmonary blood volume COPD: Subjects with COPD who regularly visit Hokkaido university hospital.PH: Subjects who have the diagnosis of PH or are suspected of PH and regularly visit Hokkaido university hospital
Key exclusion criteria
1.Subjects who had participated in
other clinical trials within the past one month.
2.Subjects who will not follow the study protocol.
3.Subjects who are pregnant or who are during the lactating period and who are suspected of pregnancy.
4.Subjects who do not agree with contraception during the study.
5. Subjects who principal investigators or members of this research consider not to be suitable for this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kaoruko Shimizu |
Organization
Hokkaido University Hospital
Division name
First department of medicine
Zip code
Address
North 15 West 7, Kita-ku, Sapporo
TEL
011-706-5911
kaorukoshimizu@pop.med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kaoruko Shimizu |
Organization
Hokkaido Univertisy Hospital
Division name
First department of medicine
Zip code
Address
North 15 West 7, Kita-ku, Sapporo
TEL
011-706-5911
Homepage URL
kaorukoshimizu@pop.med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 19 | 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
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 24 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 15 | Day |
Last modified on
| 2019 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034956
