UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047534 |
|---|---|
| Receipt number | R000054130 |
| Scientific Title | Impact of Endovascular Treatment on Peripheral Vascular Disease |
| Date of disclosure of the study information | 2022/04/20 |
| Last modified on | 2022/04/20 15:26:34 |
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Basic information
Public title
Impact of Endovascular Treatment on Peripheral Vascular Disease
Acronym
Endovascular Treatment and Peripheral Vascular Disease
Scientific Title
Impact of Endovascular Treatment on Peripheral Vascular Disease
Scientific Title:Acronym
Endovascular Treatment and Peripheral Vascular Disease
Region
| Japan |
Condition
Condition
peripheral vascular disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the impact of endovascular treatment on peripheral vascular disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationships between thigh muscle mass, blood glucose, and apolipoproteins
Key secondary outcomes
Relationships between the changes in thigh muscle mass, blood glucose, and apolipoproteins
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 with peripheral vascular disease
above 20 years old
Key exclusion criteria
maintenance hemodialysis
contrast medium allergy
pregnant women or the women who may become pregnant and nursing
pacemaker implantation
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masamichi |
| Middle name | |
| Last name | Takano |
Organization
Nippon Medical School Chiba Hokusoh Hospital
Division name
Cardiovascular center
Zip code
270-1694
Address
1715 Kamagri Inzai Chiba
TEL
0476-99-1111
takanom@nms.ac.jp
Public contact
Name of contact person
| 1st name | Hidenori |
| Middle name | |
| Last name | Komiyama |
Organization
Nippon Medical School Chiba Hokusoh Hospital
Division name
Cardiovascular center
Zip code
270-1694
Address
1715 Kamagri Inzai Chiba
TEL
0476-99-1111
Homepage URL
h-komiyama0317@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School Chiba Hokusoh Hospital
Institute
Department
Personal name
Funding Source
Organization
Nippon Medical Chiba Hokusoh 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
Nippon Medical School Chiba Hokusoh Hospital
Address
1715 Kamagri Inzai Chiba
Tel
0476991111
nms_hokusohrinri.group@nms.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
| 2022 | Year | 04 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 04 | Month | 25 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Thigh muscle volume would be measured with computed tomography in peripheral vascular disease before and after endovascular treatment. Concomitant evaluation of metabolism in glucose and lipid would be evaluated.
Management information
Registered date
| 2022 | Year | 04 | Month | 20 | Day |
Last modified on
| 2022 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054130
