UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033497
Receipt No. R000038199
Scientific Title Study on pulmonary perfusion blood flow and prognosis of venous thromboembolism
Date of disclosure of the study information 2018/07/25
Last modified on 2018/07/24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Study on pulmonary perfusion blood flow and prognosis of venous thromboembolism
Acronym pulmonary perfusion blood flow
Scientific Title Study on pulmonary perfusion blood flow and prognosis of venous thromboembolism
Scientific Title:Acronym 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
1st name
Middle name
Last name Daisuke Sueta
Organization Kumamoto University Hospital
Division name Cardiovascular Medicine
Zip code
Address 1-1-1 Honjo, Kumamoto
TEL 096-373-5175
Email sueta-d@kumamoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Sueta
Organization Kumamoto University Hospital
Division name Cardiovascular Medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2018 Year 07 Month 24 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.