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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000002689
Receipt No. R000003284
Scientific Title Evaluation of pulmonary circulation dynamics by using CT perfusion technique.
Date of disclosure of the study information 2009/10/30
Last modified on 2009/10/29

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Basic information
Public title Evaluation of pulmonary circulation dynamics by using CT perfusion technique.
Acronym Evaluation of pulmonary circulation dynamics by using CT perfusion technique.
Scientific Title Evaluation of pulmonary circulation dynamics by using CT perfusion technique.
Scientific Title:Acronym Evaluation of pulmonary circulation dynamics by using CT perfusion technique.
Region
Japan

Condition
Condition pulmonary hypertension
Classification by specialty
Pneumology Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Less invasively evaluating pulmonary circulation dynamics in pulmonary hypertension by using CT perfusion technique.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Correlation between estimated pulmonary arterial pressure by CT perfusion and directly measured pulmonary arterial pressure
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 CT perfusion study by contrast enhancement
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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patient with pulmonary hypertension or presumed case
Key exclusion criteria Children younger than 15 years old
Contraindication of contrast enhanced CT such as severe renal dysfunction or history of allergy for contrast agent, etc.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fumikazu Sakai
Organization Saitama Medical University International Medical Center
Division name Department of Diagnostic Radiology
Zip code
Address 1397-1, Yamane, Hidaka, Saitama
TEL 042-984-4520
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takeyuki Watadani
Organization Saitama Medical University International Medical Center
Division name Department of Diagnostic Radiology
Zip code
Address 1397-1, Yamane, Hidaka, Saitama
TEL 042-984-4520
Homepage URL
Email watadani@saitama-med.ac.jp

Sponsor
Institute Department of Diagnostic Radiology, Saitama Medical University International Medical Center
Institute
Department

Funding Source
Organization Nothing
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 埼玉医科大学国際医療センター(埼玉県)

Other administrative information
Date of disclosure of the study information
2009 Year 10 Month 30 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 Preinitiation
Date of protocol fixation
2009 Year 10 Month 14 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2011 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 10 Month 29 Day
Last modified on
2009 Year 10 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003284

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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