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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007999
Receipt No. R000009343
Scientific Title Role of CT and SPECT in the assessment of therapeutic effect of anticoagulation or thrombolytic therapy for pulmonary thromboemboslism
Date of disclosure of the study information 2012/06/01
Last modified on 2015/05/21

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Basic information
Public title Role of CT and SPECT in the assessment of therapeutic effect of anticoagulation or thrombolytic therapy for pulmonary thromboemboslism
Acronym ROL of CT and SPECT in the PTE
Scientific Title Role of CT and SPECT in the assessment of therapeutic effect of anticoagulation or thrombolytic therapy for pulmonary thromboemboslism
Scientific Title:Acronym ROL of CT and SPECT in the PTE
Region
Japan

Condition
Condition pulmonary thromboembolism
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the frequncy of natural history and transition from acute to chronic pulmonary thromboembolism in a theree-year period.

Basic objectives2 Others
Basic objectives -Others none
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Transition of acute pulmonary thromboembolism to chronic thromboembolic pulmonary hypertension
Key secondary outcomes Findings of CT pulmonary angiography and SPECT
RV dimension, RV dyssynergy and estimated PA pressure on cardica US

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 Diagnosis
Type of intervention
Other
Interventions/Control_1 CT pulmonary agngiography
CT venography
lung perfusin SPECT
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients diagnosed as acute pulmonary thromboembolism with CT paulmonary angiographt
Key exclusion criteria Past history of pulmonary thromboembolsim
Target sample size 36

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeru Kosuda
Organization Self Defence Meidical School
Division name Department of Radiology
Zip code
Address Namiki 1-1, Tokorozawa, Saitama
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Self Defence Meidical School
Division name Department of Radiology
Zip code
Address Namiki 1-1, Tokorozawa, Saitama
TEL
Homepage URL
Email

Sponsor
Institute Postgraduate School, Saitama Meidcal University
Institute
Department

Funding Source
Organization Postgraduate School, Saitama Meidcal University
Organization
Division
Category of Funding Organization Self funding
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 埼玉医科大学死総合医療センター放射線科、心臓内科、呼吸器内科、呼吸器外科(埼玉県)

Other administrative information
Date of disclosure of the study information
2012 Year 06 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 Terminated
Date of protocol fixation
2012 Year 05 Month 16 Day
Date of IRB
Anticipated trial start date
2012 Year 08 Month 01 Day
Last follow-up date
2016 Year 08 Month 01 Day
Date of closure to data entry
2016 Year 09 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 05 Month 21 Day
Last modified on
2015 Year 05 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009343

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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