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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019880
Receipt No. R000022852
Scientific Title Noninvasively aortic aneurysm diagnosis by examining pathognomonic reflected wave in thoracic aortic aneurysm
Date of disclosure of the study information 2015/11/21
Last modified on 2019/04/03

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Basic information
Public title Noninvasively aortic aneurysm diagnosis by examining pathognomonic reflected wave in thoracic aortic aneurysm
Acronym Noninvasively aortic aneurysm diagnosis by examining pathognomonic reflected wave in thoracic aortic aneurysm
Scientific Title Noninvasively aortic aneurysm diagnosis by examining pathognomonic reflected wave in thoracic aortic aneurysm
Scientific Title:Acronym Noninvasively aortic aneurysm diagnosis by examining pathognomonic reflected wave in thoracic aortic aneurysm
Region
Japan

Condition
Condition Thoracic aortic aneurysm
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether there is specific pulse wave in patients with thoracic aortic aneurysm or not.
Basic objectives2 Others
Basic objectives -Others To investigate whether the site of thoracic aortic aneurysm could affect the specific pulse wave.
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes To detect the specific pulse wave caused by aortic aneurysm.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 We record the pulse wave at left and right carotid and femoral arteries by using ultrasonography in a patient group in preoperative period once for 30 min.
Interventions/Control_2 In a control group, the same procedure is performed.
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 The patient with thoracic aortic aneurysm.
Healthy adults as a control group.
Informed consent has already acquired.
Key exclusion criteria The patient who needs urgent hospitalization.
The patient that ability for judgment is not enough.
The patient who cannot keep rest for some reason.
Minor
Target sample size 24

Research contact person
Last name of lead principal investigator
1st name Yoshikatsu
Middle name
Last name Saiki
Organization Tohoku University Graduate School of Medicine
Division name Division of Cardiovascular Surgery
Zip code 9818574
Address 1-1, Seiryo-machi, Aoba-ku, Sendai, Japan
TEL 022-717-7222
Email yoshisaiki@med.tohoku.ac.jp

Public contact
1st name of contact person
1st name Yoshikatsu
Middle name
Last name Saiki
Organization Tohoku University Graduate School of Medicine
Division name Division of Cardiovascular Surgery
Zip code 9818574
Address 1-1, Seiryo-machi, Aoba-ku, Sendai, Japan
TEL 022-717-7222
Homepage URL
Email yoshisaiki@med.tohoku.ac.jp

Sponsor
Institute Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization Under application
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 Tohoku University School of Medicine, IRB
Address 2-1, Seiryo-machi, Aoba-ku, Sendai
Tel 022-728-4105
Email med-kenkyo@grp.tohoku.ac.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
2015 Year 11 Month 21 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 0
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 Completed
Date of protocol fixation
2015 Year 11 Month 13 Day
Date of IRB
2015 Year 09 Month 29 Day
Anticipated trial start date
2015 Year 11 Month 16 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 11 Month 20 Day
Last modified on
2019 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022852

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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