UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016338 |
|---|---|
| Receipt number | R000018959 |
| Scientific Title | Evaluation of right ventricle and small vascular disease by using FDG-PET and BMIPP analogue imaging in patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension |
| Date of disclosure of the study information | 2015/02/01 |
| Last modified on | 2015/01/26 11:10:20 |
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Basic information
Public title
Evaluation of right ventricle and small vascular disease by using FDG-PET and BMIPP analogue imaging in patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
Acronym
vascular disease by using FDG-PET and BMIPP analogue imaging in patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
Scientific Title
Evaluation of right ventricle and small vascular disease by using FDG-PET and BMIPP analogue imaging in patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
Scientific Title:Acronym
vascular disease by using FDG-PET and BMIPP analogue imaging in patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
Region
| Japan |
Condition
Condition
pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Mitochondrial remodeling of right venticle myocytes and pulmonary vascular cells in patients with PAH and CTEPH
Basic objectives2
Others
Basic objectives -Others
Evaluation of small vasular alterations in CTEPH
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
An accumulation of glucose and fatty acid in right ventricle and vasculature
Key secondary outcomes
Evaluation of small vascular remodeling in CTEPH and a correlation between glucose and fatty acid accumulation and pulmonary hemodynamics
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
FDG-PET and BMIPP analogue imaging
Interventions/Control_2
lung biopsy in CTEPH patients
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)regardless of age or sex
2)mPAP>25mmHg in RHC
3)CTEPH who will undergo a PEA operation
4)patients with a written informed consent form
Key exclusion criteria
1)patients who are supposed to be unsuitable for this study by a study director
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seiichiro Sakao |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Respirology (B2)
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL
043-222-7171
sakaos@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seiichiro Sakao |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Respirology (B2)
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL
043-222-7171
Homepage URL
sakaos@faculty.chiba-u.jp
Sponsor or person
Institute
Department of Respirology (B2),Graduate School of Medicine, Chiba University
Institute
Department
Personal name
Funding Source
Organization
Money of authorized accounting of Department of Respirology
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
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 01 | 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
| 2011 | Year | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 26 | Day |
Last modified on
| 2015 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018959
