UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008762 |
|---|---|
| Receipt number | 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 | 2023/03/03 09:02:35 |
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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
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
Sponsor or person
Institute
Department of Cardiovascular Medicine,
Juntendo University School of Medicine
Institute
Department
Personal name
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
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
Terminated
Date of protocol fixation
| 2012 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2012 | Year | 09 | Month | 01 | Day |
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
| 2023 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010293
