UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008436 |
|---|---|
| Receipt number | R000009924 |
| Scientific Title | Registry study of minimum or regular dose contrast PCI in patients with chronic kidney disease group 4 & 5 not on dialylsis. |
| Date of disclosure of the study information | 2012/07/14 |
| Last modified on | 2012/07/14 10:20:11 |
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Basic information
Public title
Registry study of minimum or regular dose contrast PCI in patients with chronic kidney disease group 4 & 5 not on dialylsis.
Acronym
MINICON study
Scientific Title
Registry study of minimum or regular dose contrast PCI in patients with chronic kidney disease group 4 & 5 not on dialylsis.
Scientific Title:Acronym
MINICON study
Region
| Japan |
Condition
Condition
Coronary artery disease with chronic kidney disease (estimated glomerular filtration rate <30)
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To survey real world data of percutaneous coronary intervention (PCI) in patients with chronic kidney disease (eGFR<30)
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Composite outcome of all cause death and induction of hemodialysis at 1 year
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
eGFR<30
PCI was performed
Elective case
Key exclusion criteria
Maintenance dialysis
acute coronary syndrome
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Ikari |
Organization
Tokai University
Division name
Cardiovascular Medicine
Zip code
Address
143 Shimokasuya, Isehara, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sachiko Yajima |
Organization
Tokai University
Division name
Cardiovascular Medicine
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
Funding Source
Organization
Daiichi Sankyo Pharmaceutical company
Organization
Division
Category of Funding Organization
Profit organization
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
東海大学（神奈川県）、名古屋第二赤十字病院（愛知県）、野崎徳洲会病院（大阪府）、慈恵医科大学柏病院（千葉県）、国立病院京都医療センター（京都府）、名古屋徳州会病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 14 | 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
Completed
Date of protocol fixation
| 2010 | Year | 03 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Following PCI for patients with CKD, mortality and induction of maintenance dialysis rates were observed.
Management information
Registered date
| 2012 | Year | 07 | Month | 14 | Day |
Last modified on
| 2012 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009924
