UMIN-CTR Clinical Trial

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
Email	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
Email	h-komiyama0317@nms.ac.jp

Sponsor
Institute	Nippon Medical School Chiba Hokusoh Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054130