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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042317
Receipt No. R000048309
Scientific Title Angioscopy-guided Intervention and Evaluating Arterial and Venous Atherosclerosis in Pulmonary Embolism
Date of disclosure of the study information 2021/12/01
Last modified on 2020/11/02

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Basic information
Public title Angioscopy-guided Intervention and Evaluating Arterial and Venous Atherosclerosis in Pulmonary Embolism
Acronym Angioscopy-guided Intervention and Evaluating Arterial and Venous Atherosclerosis in Pulmonary Embolism
Scientific Title Angioscopy-guided Intervention and Evaluating Arterial and Venous Atherosclerosis in Pulmonary Embolism
Scientific Title:Acronym Angioscopy-guided Intervention and Evaluating Arterial and Venous Atherosclerosis in Pulmonary Embolism
Region
Japan

Condition
Condition Pulmonary Embolism, Vessel abnormality (Aorta, venous system)
Classification by specialty
Cardiology Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To detect vessel abnormality such as aortic and venous plaques and injuries, to evaluate the incidence and character and examine the relationship between aortic, coronary , and embolic disease
Basic objectives2 Others
Basic objectives -Others observational, cross sectional
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes respiratory failure
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Pulmonary embolism
Key exclusion criteria cardiogenic shock without hemodynamic support, aortic disease which needed emergent operation, allergy to contrast media, and pregnancy
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Sei
Middle name
Last name Komatsu
Organization Osaka Gyoumeikan Hospital
Division name Cardiovascular Center
Zip code 5540012
Address 5-4-8, Nishikujo, Konohana, Japan
TEL 0664620261
Email plaquemap@yahoo.co.jp

Public contact
Name of contact person
1st name Sei
Middle name
Last name Komatsu
Organization Osaka Gyoumeikan Hospital
Division name Cardiovascular Center
Zip code 5540012
Address 5-4-8, nishi-kujo, Konohana, Osaka
TEL 0664620261
Homepage URL
Email plaquemap@yahoo.co.jp

Sponsor
Institute Osaka Gyoumeikan Hospital
Institute
Department

Funding Source
Organization Osaka Gyoumeikan Hospital
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 Osaka Gyoumeikan Hospital
Address 5-4-8, Nishikujo, Konohana, Japan
Tel 0664620261
Email t.kawanishi@gyoumeikan.or.jp

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
2021 Year 12 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 Open public recruiting
Date of protocol fixation
2016 Year 12 Month 13 Day
Date of IRB
2016 Year 12 Month 16 Day
Anticipated trial start date
2016 Year 12 Month 17 Day
Last follow-up date
2021 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Characteristics of Vessels such as aortic and coronary injuries and venous system are compared among biomarkers, pathological ways and clinical characteristics.

Management information
Registered date
2020 Year 11 Month 02 Day
Last modified on
2020 Year 11 Month 02 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048309

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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