UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000011264
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Last 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
Email mikumosatie@gmail.com

Public contact
1st 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
Email mikumosatie@gmail.com

Sponsor
Institute Osaka City University
Institute
Department

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
Email

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
URL(English) https://upload.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
Registered date File name


Contact us.