UMIN-CTR Clinical Trial

Basic information
Public title	Impact of lipid disorder on peripheral arterial disease
Acronym	Impact of lipid disorder on peripheral arterial disease
Scientific Title	Impact of lipid disorder on peripheral arterial disease
Scientific Title:Acronym	Impact of lipid disorder on peripheral arterial disease
Region	Japan

Condition
Condition	Peripheral arterial disease
Classification by specialty	Vascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to define the frequency of familial hypercholesterolemia in patients with peripheral arterial disease, and to investigate the impact of lipid disorder on the severity of peripheral arterial disease.
Basic objectives2	Others
Basic objectives -Others	1. Define the prevalence of familial hypercholesterolemia in patients with peripheral arterial disease by investigating patient characteristic, physical examination, and blood test. 2. Assess the impact of lipid disorder on the severity of peripheral arterial disease by examining lipid blood markers.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Prevalence of familial hypercholesterolemia in patients with peripheral arterial disease
Key secondary outcomes	Association between the severity of peripheral arterial disease and lipid marker

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Maneuver
Interventions/Control_1	Collect blood to investigate lipid profile for research
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	1. Patients with peripheral arterial disease diagnosed by ankle-brachial index less than 0.9. 2. Patients not rejecting the participation of this study
Key exclusion criteria	1.Patients with limb ischemia due to non-atherosclerosis vascular disease including acute limb ischemia or Buerger disease 2. Patients with limb ischemia due to vasculitis or collagen disease 3. Patients who cannot investigate patient history or family history because of dementia 4. Patients judged not eligible in this study
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Hiroyoshi Middle name Last name Komai
Organization	Kansai Medical University Medical Center
Division name	Vascular Surgery
Zip code	5708507
Address	10-15 Fumizono-cho, Moriguchi, Osaka, Japan
TEL	06-6992-1001
Email	komaihir@takii.kmu.ac.jp

Public contact
Name of contact person	1st name Hiroyoshi Middle name Last name Komai
Organization	Kansai Medical University Medical Center
Division name	Vascular Surgery
Zip code	5708507
Address	10-15 Fumizono-cho, Moriguchi, Osaka, Japan
TEL	06-6992-1001
Homepage URL
Email	komaihir@takii.kmu.ac.jp

Sponsor
Institute	Department of Vascular Surgery, Kansai Medical University Medical Center
Institute
Department

Funding Source
Organization	Kansai Medical University Medical Center
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	Kansai Medical University Center for Ethical Review
Address	2-5-1 Shin-machi, Hirakata-shi, Osaka, Japan
Tel	072-804-2440
Email	rinriirb@hirakata.kmu.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	関西医科大学総合医療センター（大阪府）、国立病院機構京都医療センター（京都府）、淀川キリスト教病院（大阪府）、大阪府済生会吹田病院（大阪府）、兵庫県立淡路医療センター（兵庫県）、新須磨病院（兵庫県）、大阪労災病院（大阪府）、済生会和歌山病院（和歌山県）、兵庫県立姫路循環器病センター（兵庫県）、神戸労災病院（兵庫県）、市立豊中病院（大阪府）、蒼龍会井上病院（大阪府）、大阪大学病院（大阪府）、松尾クリニック（大阪府）、国立循環器病センター研究所（大阪府）

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 04 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
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	2017 Year 05 Month 12 Day
Date of IRB	2017 Year 05 Month 12 Day
Anticipated trial start date	2017 Year 07 Month 04 Day
Last follow-up date	2021 Year 12 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	2017 Year 07 Month 03 Day
Last modified on	2020 Year 08 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032121