UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011264 |
|---|---|
| Receipt number | R000013184 |
| Scientific Title | Protection from Contrast Induced Nephropathy with Remote Ischemic Conditioning |
| Date of disclosure of the study information | 2013/07/24 |
| Last modified on | 2016/01/24 15:13:03 |
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Basic information
Public title
Protection from Contrast Induced Nephropathy with Remote Ischemic Conditioning
Acronym
Remote Ischemic Conditioning and Contrast Induced Nephropathy
Scientific Title
Protection from Contrast Induced Nephropathy with Remote Ischemic Conditioning
Scientific Title:Acronym
Remote Ischemic Conditioning and Contrast Induced Nephropathy
Region
| Japan |
Condition
Condition
Subjects with CKD (eGFR < 60ml/min/m2) undergoing elective CAG and PCI
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether contrast induced nephropathy can be protected by remote ischemic conditioning before or after CAG/PCI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The occurence of contrast induced nephropathy
Key secondary outcomes
MACE (death, cardiac infarction, revascularisation) at 1 year.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
No treatment
Interventions/Control_2
Remote ischemic conditioning before CAG/PCI
Interventions/Control_3
Remote ischemic conditioning after CAG/PCI
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
1: Subjects of CKD (eGFR<60 ml/min/m2) on schedule of elective CAG/PCI
2: Informed consent to this study
3: Over 20 years old on entry into this study
Key exclusion criteria
1: Acute myocardial infarction and cardiac shock
2: Continuous hemodialysis
3: Arterial sclerosis obliterans
4: Existence of malignant neoplasms needing treatment, hard pursuit for removal and difficulty of attending hospital
5: Patients whom the principal investigator judged to be inappropriate as a subject
Target sample size
270
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Minoru Yoshiyama |
Organization
Osaka City University Graduate School of Medicine
Division name
Cardiovascular Medicine
Zip code
Address
1-5-7, Asahimachi, Abenoku, Osaka City, Japan
TEL
0666452121
mikumosatie@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mikumo Sakaguchi |
Organization
Osaka City University Graduate School of Medicine
Division name
Cardiovascular Medicine
Zip code
Address
1-5-7, Asahimachi, Abenoku, Osaka City, Japan
TEL
06-6645-2121
Homepage URL
mikumosatie@gmail.com
Sponsor or person
Institute
Osaka City University
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
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 24 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 07 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 24 | Day |
Last modified on
| 2016 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013184
| 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 |
