UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on pulmonary perfusion blood flow and prognosis of venous thromboembolism
Title of the study (Brief title)	pulmonary perfusion blood flow
Region	Japan

Condition
Condition	Venous thromboembolism
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Venous thromboembolism is a disease that is occasionally lethal due to pulmonary embolism, and it is one of diseases with a high incidence in university hospitals dealing with many malignant diseases. IQon Spectral CT newly introduced at our hospital since January this year is a multi-slice CT equipped with a dual layer detector, and spectral imaging by this CT is based on incident X-rays obtained by spectroscopy of continuous X- Multiple energy and its accompanying substance interactions are utilized, and composite image analysis results and new substance information by conventional CT images and various spectral images can be obtained in all inspections. As a result, not only anatomical findings but also information on lung perfusion blood flow rate can be obtained for pulmonary embolism (D. Sueta, D. Utsunomiya et al.. Anticoagulation therapy has been established as the first choice for treatment of pulmonary embolism, but its efficacy evaluation has not been sufficiently elucidated. By evaluating lung perfusion blood flow before and after the treatment of patients who evaluated images in our venous thromboembolic event this time we can quantitatively evaluate their efficacy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	We investigate lung perfusion blood flow before and after treatment.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	1 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	We will cover all patients with venous thromboembolism from January to March, Heisei era.
Key exclusion criteria	none
Target sample size	500

Research contact person
Name of lead principal investigator	Daisuke Sueta
Organization	Kumamoto University Hospital
Division name	Cardiovascular Medicine
Address	1-1-1 Honjo, Kumamoto
TEL	096-373-5175
Email	sueta-d@kumamoto-u.ac.jp

Public contact
Name of contact person	Daisuke Sueta
Organization	Kumamoto University Hospital
Division name	Cardiovascular Medicine
Address	1-1-1 Honjo, Kumamoto
TEL	096-373-5175
Homepage URL
Email	sueta-d@kumamoto-u.ac.jp

Sponsor
Institute	Kumamoto University Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	YES
Study ID_1	Senshin 2243
Org. issuing International ID_1	Senshin 2243
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 07 Month 25 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 07 Month 24 Day
Anticipated trial start date	2018 Year 07 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	None

Management information
Registered date	2018 Year 07 Month 24 Day
Last modified on	2018 Year 07 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038199