UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028056
Receipt number R000032121
Scientific Title Impact of lipid disorder on peripheral arterial disease
Date of disclosure of the study information 2017/07/04
Last modified on 2020/08/13 20:31:04

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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 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 or person

Institute

Department of Vascular Surgery, Kansai Medical University Medical Center

Institute

Department

Personal name



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

Value
https://center6.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