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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033644
Receipt No. R000038361
Scientific Title Study on pulmonary function imaging diagnosis by chest X-ray dynamics photographing with motion picture compatible flat panel detector.Application 1 in emergency area: For pulmonary embolism patients.
Date of disclosure of the study information 2018/08/10
Last modified on 2019/02/21

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Basic information
Public title Study on pulmonary function imaging diagnosis by chest X-ray dynamics photographing with motion picture compatible flat panel detector.Application 1 in emergency area: For pulmonary embolism patients.
Acronym Clinical application of chest x-ray dynamic photography 1
Scientific Title Study on pulmonary function imaging diagnosis by chest X-ray dynamics photographing with motion picture compatible flat panel detector.Application 1 in emergency area: For pulmonary embolism patients.
Scientific Title:Acronym Clinical application of chest x-ray dynamic photography 1
Region
Japan

Condition
Condition pulmonary embolism
Classification by specialty
Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the diagnostic ability of pulmonary embolism patients with chest x-ray dynamic imaging and contrast CT
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Sensitivity for diagnosis of pulmonary embolism in measurement method of heart rate variation of permeability of 18 lung fields by chest X-ray dynamic imaging apparatus with contrast CT examination as a reference
Key secondary outcomes specificity for diagnosis of pulmonary embolism in measurement method of heart rate variation of permeability of 18 lung fields by chest X-ray dynamic imaging apparatus with contrast CT examination as a reference
Sensitivity and specificity of pulmonary embolism diagnosis of blood flow mapping image by chest x-ray dynamic imaging device

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Chest x-ray dynamic photography
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 1) Be an adult over 20 years old
2) Written informed consent
3) Patients suspected of pulmonary embolism or patients diagnosed with pulmonary embolism
4) Chest CT contrast test scheduled for diagnosis or follow-up of pulmonary embolism
Key exclusion criteria 1) have allergy to the contrast agent
2) During pregnancy, possibility of pregnancy, delivery within 28 days, breast-feeding
3) Psychiatric disorder or psychiatric symptoms are merged and it is judged difficult to participate in the trial
4) Severe cases (during artificial respiration, SpO2 <93% even when administered oxygen, wearing an extracorporeal circulation assisting device, shock index> 1, during noradrenaline administration, GCS <13)
5) Even if it does not apply to 4) above, the patient who judged treatment as priority by the attending physician
Target sample size 50

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name SHIMADA JIRO
Organization Fukushima Medical University
Division name Futaba Emergency General Medical Support Center
Zip code
Address 1 Hikariga-oka, Fukushima City, JAPAN
TEL 0245471111
Email jshimada@fmu.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name SHIMADA JIRO
Organization Fukushima Medical University hospital
Division name Emergency and Critical Care Center
Zip code
Address 1 Hikariga-oka, Fukushima City, JAPAN
TEL 0245471111
Homepage URL
Email jshimada@fmu.ac.jp

Sponsor
Institute Fukushima Medical University
Institute
Department

Funding Source
Organization Konica Minolta Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
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
2018 Year 08 Month 10 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 Open public recruiting
Date of protocol fixation
2017 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 01 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
2018 Year 08 Month 06 Day
Last modified on
2019 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038361

Research Plan
Registered date File name
2019/02/21 4認定臨床研究計画書 .pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name


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