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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000010751
Receipt No. R000012564
Scientific Title Study on contrast-induced nephropathy preventive effect of remote preconditioning in elective PCI patients
Date of disclosure of the study information 2013/05/17
Last modified on 2015/11/17

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Basic information
Public title Study on contrast-induced nephropathy preventive effect of remote preconditioning in elective PCI patients
Acronym Study on contrast-induced nephropathy preventive effect of remote preconditioning in elective PCI patients
Scientific Title Study on contrast-induced nephropathy preventive effect of remote preconditioning in elective PCI patients
Scientific Title:Acronym Study on contrast-induced nephropathy preventive effect of remote preconditioning in elective PCI patients
Region
Japan

Condition
Condition CKD inhospital patients(eGFR<60ml/min/m2) undergoing elective PCI
Classification by specialty
Cardiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate whether the preconditioning done before coronary angioplasty has a kidney protection effect or not, and to examine the appropriate method.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes *Change of creatinine level in acute and chronic phases before and after of the CI treatment
*Change of the urinary L-FABP level(CIN or not)
Key secondary outcomes MACE(death,cardiac infarction,target vessel retreatment: Having RIPC or not, Are there difference having CIN or not?, microglobulin in the urine, erythropoietin in the blood : Mechanism of CIN onset, Guess the mechanism of the effect of RIPC)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 *Press an upper arm with a cuff of sphygmoxcmanometer for 5 minutes(systolic blood pressure+50mmHg) for 30-60 minutes before the procedure.
*Rest quietly in bed for 5 minutes after the pressure being released, and press again for 5 minutes.
*Perform two sets in total.(5 minutes press and 5 minutes release)
Interventions/Control_2 *Press an upper arm with a cuff of sphygmoxcmanometer for 5 minutes(systolic blood pressure+50mmHg) for 30-60 minutes before the procedure.
*Rest quietly in bed for 5 minutes after the pressure being released, and press again for 5 minutes.
*Perform four sets in total.(5 minutes press and 5 minutes release)
Interventions/Control_3 *Press an upper arm with a cuff of sphygmoxcmanometer for 5 minutes(systolic blood pressure+10mmHg) for 30-60 minutes before the procedure.
*Rest quietly in bed for 5 minutes after the pressure being released, and press again for 5 minutes.
*Perform two sets in total.(5 minutes press and 5 minutes release)
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 who are over 20 years old at the time of obtaining informed consent
*The patient gave document agreement with the free will of himself, after receiving a sufficient explanation on participation in this study and on top of full understanding by himself.
Key exclusion criteria *Patients receiving dialysis
*Patients having any cancer
*Patients who have difficulty with pessing upper arm in mentally or physically
*Patients who don't give the consent of the participants to the test
*Patients whom the principal investigator judged to be inappropriate as a subject
Target sample size 180

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yusuke IWASAKI
Organization Osaka General Medical Center
Division name Cardiac internal medicine
Zip code
Address 3-1-56,Bandaihigashi, Sumiyoshi-ku, Osaka
TEL 06-6692-1201
Email kenkyusien@gh.opho.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yusuke IWASAKI
Organization Osaka General Medical Center
Division name Cardiac internal medicine
Zip code
Address 3-1-56,Bandaihigashi, Sumiyoshi-ku, Osaka
TEL 06-6692-1201
Homepage URL
Email kenkyusien@gh.opho.jp

Sponsor
Institute Osaka General Medical Center
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 05 Month 17 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 Terminated
Date of protocol fixation
2013 Year 02 Month 23 Day
Date of IRB
Anticipated trial start date
2013 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

Management information
Registered date
2013 Year 05 Month 17 Day
Last modified on
2015 Year 11 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012564

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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