UMIN-CTR Clinical Trial

Basic information
Public title	Effect of percutaneous transluminal angioplasty on endothelial function in patients with peripheral arterial disease
Acronym	Effect of percutaneous transluminal angioplasty on endothelial function in patients with peripheral arterial
Scientific Title	Effect of percutaneous transluminal angioplasty on endothelial function in patients with peripheral arterial disease
Scientific Title:Acronym	Effect of percutaneous transluminal angioplasty on endothelial function in patients with peripheral arterial
Region	Japan

Condition
Condition	Peripheral arterial disease
Classification by specialty	Medicine in general Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate acute and chronic effects of percutaneous transluminal angioplasty on endothelial function and myokines in patients with peripheral arterial disease.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1) Change of endothelial function by Endo-PAT 2) Change of circulating levels of myolines (Follistatin-like 1, IL-6, IL-7, IGF-1, FGF-2) 3) change of peripheral blood mononuclear cellprofileand numbers of endothelial progenitor cells and hematopoietic cells.
Key secondary outcomes	1) Fontaine classification 2) Ankle brachial index 3) Skin perfusion pressure 4) Body weight, body mass index, blood pressure, muscle mass of lower legs 5) hs CRP levels 6) Renal function and liver fuction tests

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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Purpose of intervention
Type of intervention
Interventions/Control_1
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Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients with peripheral arterial disease who are scheduled for an elective percutaneous transluminal angioplasty. 2) Patients wituout peripheral arterial disease and coronary heart disease are enrolled as controls. 3) Patients who give informed consent.
Key exclusion criteria	1) Patients who receive hemodialysis. 2) Patients who had received amputation of any lims. 3) Patients who are scheduled for a percutaneous transluminal angioplasty for the lesion below knee. 4) Patients who are scheduled for a percutaneous coronary intervention within a month. 5) Patients who had experienced acute coronary syndrome within 6 months. 6) Patients who have systemic inflammatory diseases including collagen diseases and infections. 7) Patients judged to be unsuitable participants by physician-in-charge.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tetsuro Miyazaki
Organization	Juntendo University Hospital
Division name	Department of Cardiovascular Medicine
Zip code
Address	Hongo 3-1-3, Bunkyo-ku, Tokyo, Japan
TEL	03-3813-3111
Email

Public contact
Name of contact person	1st name Middle name Last name Tetsuro Miyazaki
Organization	Juntendo University Hospital
Division name	Department of Cardiovascular Medicine
Zip code
Address	Hongo 3-1-3, Bunkyo-ku, Tokyo, Japan
TEL	03-3813-3111
Homepage URL
Email

Sponsor
Institute	Department of Cardiovascular Medicine, Juntendo University School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
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IRB Contact (For public release)
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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	2012 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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Results
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Baseline Characteristics
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Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2012 Year 07 Month 27 Day
Date of IRB
Anticipated trial start date	2012 Year 09 Month 01 Day
Last follow-up date	2014 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
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Other

Other related information

We prospectively examine endothelial function, circulating myokine levels and peripheral bloos mononuclear cell profile, and numbers of EPC and HPC at baseline, the next day of and a month after percutaneous tranluminal angioplasty in 40 patients with peripheral arterial disease. We also compare endothelial function, circulating myokine levels and peripheral bloos mononuclear cell profile, and numbers of EPC and HPC between 40 patients with peripheral arterial disease and 20 controls without peripheral arterial disease and coronary artery disease at baseline.

Management information
Registered date	2012 Year 08 Month 24 Day
Last modified on	2013 Year 02 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010293

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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