UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017331 |
|---|---|
| Receipt number | R000020108 |
| Scientific Title | Study in current status and prognosis in patients with peripheral artery disease (Showa PAD registry) |
| Date of disclosure of the study information | 2015/04/29 |
| Last modified on | 2023/05/11 15:46:37 |
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Basic information
Public title
Study in current status and prognosis in patients with peripheral artery disease (Showa PAD registry)
Acronym
Showa PAD registry
Scientific Title
Study in current status and prognosis in patients with peripheral artery disease (Showa PAD registry)
Scientific Title:Acronym
Showa PAD registry
Region
| Japan |
Condition
Condition
Peripheral artery disease
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyse the current status and prognosis in peripheral artery disease
Basic objectives2
Others
Basic objectives -Others
A multicenter epidemiology observational study to determine the frequency of the event about the characteristics of the patients group with PAD and the health and distribution and a factor to affect
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
All-cause death, cardiac death, cardiovascular death, non-cardiac death, non-cardiovascular death, admission (heart failure, myocardial infarction, cerebral infarction, critical limb ischemia), limb amputation
Key secondary outcomes
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
Ankle brachial index (ABI) <1.0
Toe brachial index (TBI) <0.6
Skin purfusion pressure (SPP) <60mmHg
Key exclusion criteria
1) Patients once registered in this study
2) Patients unable to follow up
3) Patietns with poor prognosis with cancer
4) Patietns doctors decide not eligible
5) ABI, TBI, SPP were not met the criteria after recanalization therapy
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Suzuki |
Organization
Showa Univeristy Fujigoka Hospital
Division name
Department of Cardiology
Zip code
227-8501
Address
1-30 Fujigaoka, Aoba-ku, Yokohama, Kanagawa
TEL
0459711151
hrsuzuki@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Suzuki |
Organization
Showa Univeristy Fujigoka Hospital
Division name
Department of Cardiology
Zip code
227-8501
Address
1-30 Fujigaoka, Aoba-ku, Yokohama 227-8501, Kanagawa, Jaoan
TEL
81-45-971-1151
Homepage URL
hrsuzuki@med.showa-u.ac.jp
Sponsor or person
Institute
Showa Univeristy Fujigoka Hospital
Institute
Department
Personal name
Funding Source
Organization
Showa Univeristy Fujigoka Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University Fujigaoka Hospital
Address
1-30 Fujigaoka, Aoba-ku, Yokohama, Kanagawa
Tel
0459711151
hrsuzuki@med.showa-u.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
昭和大学藤が丘病院（神奈川県）、昭和大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 29 | 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
100
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Input of data delays.
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
| 2014 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
(1) All-cause death (2) Cardiac death (3) Cardiovascular death (4) Non-cardiac death (5) Non-cardiovascular death (6) Admission in heart failure (7) Admission in myocardial infarction (8) Admission in cerebral infarcition (9) Admission in critical limb ischemia (10) Limb amputation
Management information
Registered date
| 2015 | Year | 04 | Month | 29 | Day |
Last modified on
| 2023 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020108
| Research Plan | |
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| Registered date | File name |
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