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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000030821 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | COPD, PH | |
Classification by specialty |
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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 |
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Interventions/Control_1 | 15O-H2O PET/CT | |
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Eligibility | ||||
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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
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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. |
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Target sample size | 20 |
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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 |
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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 | |
Institute | Hokkaido University |
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Funding Source | |
Organization | Japan Science and Technology Agency |
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Category of Funding Organization | Japanese Governmental office |
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Secondary IDs | NO |
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IND to MHLW |
Institutions | |
Institutions | 北海道大学病院(北海道) |
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Date of disclosure of the study information |
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Publication of results | Unpublished |
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Recruitment status | Completed | ||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034956 |
Research Plan | |
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Research case data | |
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