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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008762
Receipt No. R000010293
Scientific Title Effect of percutaneous transluminal angioplasty on endothelial function in patients with peripheral arterial disease
Date of disclosure of the study information 2012/09/01
Last modified on 2013/02/25

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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
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

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
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

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
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
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
Date analysis concluded

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
Registered date File name

Research case data
Registered date File name


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