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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028056
Receipt No. R000032121
Scientific Title Impact of lipid disorder on peripheral arterial disease
Date of disclosure of the study information 2017/07/04
Last modified on 2017/07/19

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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
Middle name
Last name Hiroyoshi Komai
Organization Kansai Medical University Medical Center
Division name Vascular Surgery
Zip code
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
Middle name
Last name Hiroyoshi Komai
Organization Kansai Medical University Medical Center
Division name Vascular Surgery
Zip code
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
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 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
Anticipated trial start date
2017 Year 07 Month 04 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
2017 Year 07 Month 03 Day
Last modified on
2017 Year 07 Month 19 Day


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

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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