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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000016338
Receipt No. 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

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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
Email 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
Email sakaos@faculty.chiba-u.jp

Sponsor
Institute Department of Respirology (B2),Graduate School of Medicine, Chiba University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018959

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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