UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019880 |
|---|---|
| Receipt number | 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 13:48:46 |
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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
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
yoshisaiki@med.tohoku.ac.jp
Public contact
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
yoshisaiki@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022852
