UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013962 |
|---|---|
| Receipt number | R000015822 |
| Scientific Title | Effect of the operation and PTA on the patency for vascular access in Tanakakitanoda |
| Date of disclosure of the study information | 2014/05/16 |
| Last modified on | 2017/06/30 15:01:49 |
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Basic information
Public title
Effect of the operation and PTA on the patency for vascular access in Tanakakitanoda
Acronym
VACT study
Scientific Title
Effect of the operation and PTA on the patency for vascular access in Tanakakitanoda
Scientific Title:Acronym
VACT study
Region
| Japan |
Condition
Condition
vascular access failure
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of the operation and PTA on the patency for vascular access
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) vascular access failure: occlusion of vascular access or intervention for the failure
2) cardiovascular events and death: stroke, coronary artery disease, peripheral artery disease, and admission for heart failure
Key secondary outcomes
1) all-cause death
2) all-cause admission
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) Cases of operation and PTA of vascular access in the Hospital of Hyogo College of Medicine and Tanakakitanoda Hospital
2) Patients with the informed consent to this study by themselves
Key exclusion criteria
Patients judged as unsuitable for participanting in this study by the attending physician
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Nakanishi |
Organization
Hyogo College of Medicine
Division name
Dep Internal Medicine, Div Kidney and Dialysis
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798456521
jin@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukiko Hasuike |
Organization
Hyogo College of Medicine
Division name
Dep Internal Medicine, Div Kidney and Dialysis
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798456521
Homepage URL
cherry39@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo College 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
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
兵庫医科大学（兵庫県），田仲北野田病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Preinitiation
Date of protocol fixation
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 16 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
Investigate the effects of clinical factors of chronic kidney disease on vascular access failure and cardiovascular events in hemodialzed patients
Management information
Registered date
| 2014 | Year | 05 | Month | 15 | Day |
Last modified on
| 2017 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015822
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
