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UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025311
Receipt No. R000029113
Scientific Title Study on the predictive value of vascular functional test for buttock claudication in patients with endovascular aneurysm repair
Date of disclosure of the study information 2016/12/21
Last modified on 2018/12/19

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Basic information
Public title Study on the predictive value of vascular functional test for buttock claudication in patients with endovascular aneurysm repair
Acronym Study on the predictive value of vascular functional test for buttock claudication in patients with endovascular aneurysm repair
Scientific Title Study on the predictive value of vascular functional test for buttock claudication in patients with endovascular aneurysm repair
Scientific Title:Acronym Study on the predictive value of vascular functional test for buttock claudication in patients with endovascular aneurysm repair
Region
Japan

Condition
Condition abdominal and iliac aneurysm
Classification by specialty
Vascular surgery Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to analyze if a vascular functional test predicts buttock pain after interventional hypogastric artery occlusion in patients with endovascular aneurysm repair
Basic objectives2 Others
Basic objectives -Others vascular functional test (Flow-mediated vasodilation / nitroglycerin-mediated vasodilation), treadmill exercise test
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes occurrences rate of buttock pain
Key secondary outcomes course of walking ability

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 vascular functional test(preoperative)/ treadmill exercise test (preoperative, postoperative after 1.2.3.4.5.6 months)
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
85 years-old >=
Gender Male and Female
Key inclusion criteria patients scheduled to be performed endovascular aneurysm repair with interventional hypogastric occlusion
Key exclusion criteria 1) buttock pain with neurogenic disorder
2) active inflammatory disease
3) contraindication for vascular functional test, treadmill exercise test
4) mental disorder
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daijirou Akamatsu
Organization Tohoku University Hospital
Division name devision of vascular surgery
Zip code
Address 1-1 Seiryo-machi, Aoba-ku Sendai, 980-8574 Japan
TEL 022-717-7214
Email daijirou@med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daijirou Akamatsu
Organization Tohoku University Hospital
Division name devision of vascular surgery
Zip code
Address 1-1 Seiryo-machi, Aoba-ku Sendai, 980-8574 Japan
TEL 022-717-7214
Homepage URL
Email daijirou@med.tohoku.ac.jp

Sponsor
Institute Tohoku University Hospital devision of vascular surgery
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
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

Other administrative information
Date of disclosure of the study information
2016 Year 12 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
Results
Now, 20 cases were included. 
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 Enrolling by invitation
Date of protocol fixation
2017 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 17 Day
Last modified on
2018 Year 12 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029113

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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