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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008939
Receipt No. R000010480
Scientific Title The relationship between spontaneous echocardiographic contrast within the aneurysm and persistent endoleaks in endovascular repair of thoracic aortic aneurysms
Date of disclosure of the study information 2012/09/18
Last modified on 2017/08/01

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Basic information
Public title The relationship between spontaneous echocardiographic contrast within the aneurysm and persistent endoleaks in endovascular repair of thoracic aortic aneurysms
Acronym The relationship between spontaneous echocardiographic contrast within the aneurysm and persistent endoleaks in endovascular repair of thoracic aortic aneurysms
Scientific Title The relationship between spontaneous echocardiographic contrast within the aneurysm and persistent endoleaks in endovascular repair of thoracic aortic aneurysms
Scientific Title:Acronym The relationship between spontaneous echocardiographic contrast within the aneurysm and persistent endoleaks in endovascular repair of thoracic aortic aneurysms
Region
Japan

Condition
Condition thoracic aortic aneurysms
Classification by specialty
Anesthesiology Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examine that the effectiveness of the detection of persistent endoleaks by spontaneous echocardiographic contrast within the aneurysm in endovascular repair of thoracic aortic aneurysms.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Persistent endoleaks at follow-up CT imaging
Key secondary outcomes Persistent endoleaks at postoperative CT imaging
Need for additional intervention

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 Patients undergoing thoracic endovascular aortic repair
Key exclusion criteria Patients with contraindication to transesophageal echocardiography
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidekazu Imai
Organization Niigata University Medical and Dental Hospital
Division name Department of Anesthesiology
Zip code
Address 1-757 Asahimachi-dori, Chuo-ku, Niigata
TEL 025-227-2328
Email hdkzimi@med.niigata-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hidekazu Imai
Organization Niigata University Medical and Dental Hospital
Division name Department of Anesthesiology
Zip code
Address 1-757 Asahimachi-dori, Chuo-ku, Niigata
TEL 025-227-2328
Homepage URL
Email hdkzimi@med.niigata-u.ac.jp

Sponsor
Institute Department of Anesthesiology, Niigata University Medical and Dental Hospital
Institute
Department

Funding Source
Organization Department of Anesthesiology, Niigata University Medical and Dental 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
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 新潟大学医歯学総合病院(新潟県)

Other administrative information
Date of disclosure of the study information
2012 Year 09 Month 18 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://journals.lww.com/anesthesia-analgesia/Abstract/2017/08000/Intraoperative_Detection_of_Persist
Number of participants that the trial has enrolled
Results Patients with spontaneous echocardiographic contrast had a higher incidence of postoperative endoleaks than did patients without spontaneous echocardiographic contrast within a few days postoperatively (60.0% vs 12.5%, respectively; P < 0.001) and at 6 months postoperatively (40.0% vs 2.5%, respectively; P < 0.001).
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 Completed
Date of protocol fixation
2010 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 14 Day
Last follow-up date
2014 Year 02 Month 01 Day
Date of closure to data entry
2014 Year 02 Month 01 Day
Date trial data considered complete
2014 Year 02 Month 01 Day
Date analysis concluded
2014 Year 03 Month 01 Day

Other
Other related information We examine that the relationship between spontaneous echocardiographic contrast within the aneurysm and persistent endoleaks at follow-up CT imaging in endovascular repair of thoracic aortic aneurysms.

Management information
Registered date
2012 Year 09 Month 18 Day
Last modified on
2017 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010480

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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