UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008272 |
|---|---|
| Receipt number | R000009699 |
| Scientific Title | Safety and Efficacy of Carbone Dioxide Angiography for endovascular therapy in patients with chronic kidney disease: Prospective multicenter observational study |
| Date of disclosure of the study information | 2012/06/28 |
| Last modified on | 2013/06/14 23:17:12 |
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Basic information
Public title
Safety and Efficacy of Carbone Dioxide Angiography for endovascular therapy in patients with chronic kidney disease: Prospective multicenter observational study
Acronym
CO2 angiography registry
Scientific Title
Safety and Efficacy of Carbone Dioxide Angiography for endovascular therapy in patients with chronic kidney disease: Prospective multicenter observational study
Scientific Title:Acronym
CO2 angiography registry
Region
| Japan |
Condition
Condition
Patients with chronic kidney disease (eGFR<60 mL/min/1.73m2) and symptomatic renal artery stenosis and/or symptomatic peripheral arterial disease ( Rutherford Classification Category 2-5)
Classification by specialty
| Cardiology | Vascular surgery | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate safety and efficacy of CO2 angiography and reduced contrast media assisted endovascular therapy for chronic kidney disease.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Worsening of renal function (serum Cr, eGFR)
Key secondary outcomes
1) Procedural success
2) Complications of procedure
3) Major adverse event (death, Myocardial infarction, end stage of renal dysfunction (renal death, renal replacement therapy),stroke, reintervenshon thrapy
4) Contrast induced nephropathy
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
Patients with chronic kidney disease (eGFR<60 mL/min/1.73m2) and symptomatic renal artery stenosis and/or symptomatic peripheral arterial disease ( Rutherford Classification Category 2-5)
Key exclusion criteria
Patients on Hemodialysis
Patients with solitary below the knee artery disease
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daizo Kawasaki |
Organization
Hyogo Collage of Medicine
Division name
Cardiovascular Division
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya City,Hyogo,Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiko Fujihara |
Organization
Kishiwada Tokushukai Hospital
Division name
Cardiovascular Division
Zip code
Address
4-27-1 Kamori-cho Kisiwada-City,Osaka,Japan
TEL
072-445-9915
Homepage URL
masahiko-fujihara@themis.ocn.ne.jp
Sponsor or person
Institute
Kishiwada Tokushukai Hospital
Hyogo Collage 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
Shin-Koga Hospital
Tokeidai Memorial Hospital
Miyazak Medical Association Hospital
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
天神会 新古賀病院
カレスサッポロ 時計台記念病院
宮崎市郡医師会病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 28 | 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
| 2012 | Year | 06 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 08 | Month | 01 | Day |
Other
Other related information
pre procedure,post procedure within 5days,1month later,3month later
Management information
Registered date
| 2012 | Year | 06 | Month | 26 | Day |
Last modified on
| 2013 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009699
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
