UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041838 |
|---|---|
| Receipt number | R000047761 |
| Scientific Title | Peripheral Vascular Disease Registry at Yokohama City University |
| Date of disclosure of the study information | 2020/09/18 |
| Last modified on | 2020/09/18 10:54:44 |
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Basic information
Public title
Peripheral Vascular Disease Registry at Yokohama City University
Acronym
YCU-PVD Registry
Scientific Title
Peripheral Vascular Disease Registry at Yokohama City University
Scientific Title:Acronym
YCU-PVD Registry
Region
| Japan |
Condition
Condition
Peripheral Vascular Disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the natural course and the prognostic predictor of peripheral vascular disease.
Basic objectives2
Others
Basic objectives -Others
To build the Registry database of peripheral vascular disease.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prognosis including death, non-fatal myocardial infarction, non-fatal stroke, bleeding, revascularization, amputation, heart failure, and pulmonary embolism.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
This study is a retrospective and prospective observational study at Yokohama City University between April 2005 to December 2029.
Patients with the diagnosis of peripheral artery and venous disease are enrolled.
Key exclusion criteria
Rejection to the Registry.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Kozo |
| Middle name | |
| Last name | Okada |
Organization
Yokohama City University Medical Center
Division name
Division of cardiology
Zip code
232-0024
Address
4-57 Urafune-cho, Minami-ku, Yokohama
TEL
+81452615656
kokada2@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Masaomi |
| Middle name | |
| Last name | Gohbara |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Medical Science and Cardiorenal Medicine
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
+81457872800
Homepage URL
gocchi3@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University
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
Institutional Review Board of Yokohama City University
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
Tel
+81453707627
rinri@yokohama-cu.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 | 18 | 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
| 2019 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
[Component of an examination]
Patients characteristics
Physical findings
Laboratory data
Physiological examination (ECG, Echo, etc)
Imaging examination (CAG, MRI, X-dar, CT, RI, IVUS/OCT/OFDI, etc)
Intervention findings
Management information
Registered date
| 2020 | Year | 09 | Month | 18 | Day |
Last modified on
| 2020 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047761
