UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025311 |
|---|---|
| Receipt number | 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 | 2022/06/22 10:07:53 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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 | Daijirou |
| Middle name | |
| Last name | Akamatsu |
Organization
Tohoku University Hospital
Division name
devision of vascular surgery
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku Sendai, 980-8574 Japan
TEL
022-717-7214
daijirou@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Daijirou |
| Middle name | |
| Last name | Akamatsu |
Organization
Tohoku University Hospital
Division name
devision of vascular surgery
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku Sendai, 980-8574 Japan
TEL
022-717-7214
Homepage URL
daijirou@surg.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital devision of vascular surgery
Institute
Department
Personal name
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
Ethics Committee Tohoku University Hospital
Address
1-1 Seiryo-machi, Aoba-ku Sendai, 980-8574 Japan
Tel
022-728-4105
ec@rinri.hosp.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
| 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
Bilateral hypogastric artery embolization has more adverse effect on the hemodynamics of the gluteal circulation and subjective symptoms than unilateral embolization. These findings may help to consider strategy of hypogastric artery reconstruction.
Results date posted
| 2020 | Year | 06 | Month | 20 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
We have written the manuscript and applied to journal.
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
| 2017 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 01 | 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
Management information
Registered date
| 2016 | Year | 12 | Month | 17 | Day |
Last modified on
| 2022 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.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 |
