UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041809 |
|---|---|
| Receipt number | R000047733 |
| Scientific Title | Prospective study on the prognosis of peripheral arterial disease |
| Date of disclosure of the study information | 2020/09/16 |
| Last modified on | 2024/03/28 21:03:46 |
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Basic information
Public title
Prospective study on the prognosis of peripheral arterial disease
Acronym
Prospective study on the prognosis of peripheral arterial disease
Scientific Title
Prospective study on the prognosis of peripheral arterial disease
Scientific Title:Acronym
Prospective study on the prognosis of 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
Predicting the prognosis of peripheral arterial disease with the general conditions and lower limb conditions
Basic objectives2
Others
Basic objectives -Others
Non-interventional observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Scoring with the general conditions and lower limb conditions
Key secondary outcomes
Scoring with the general conditions
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
Patients who underwent surgery for peripheral arterial disease in our department
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Sano |
Organization
Hamamatsu University School of Medicine
Division name
Departmento of Vascular Surgery
Zip code
4313192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka
TEL
053-435-2279
m.sano@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Sano |
Organization
Hamamatsu University School of Medicine
Division name
Departmento of Vascular Surgery
Zip code
4313192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka
TEL
053-435-2279
Homepage URL
m.sano@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka
Tel
053-435-2279
m.sano@hama-med.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 16 | 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
Completed
Date of protocol fixation
| 2020 | Year | 01 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients were divided into two groups according to the scoring systems with preoperative general conditions and lower limb conditions. Observe the prognosis up to 2 years after surgery.
Management information
Registered date
| 2020 | Year | 09 | Month | 16 | Day |
Last modified on
| 2024 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047733
