UMIN-CTR Clinical Trial

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

CKD inhospital patients(eGFR<60ml/min/m2) undergoing elective PCI

Classification by specialty

Cardiology

Classification by malignancy

Malignancy

Genomic information

NO

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

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)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Osaka General Medical Center

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

05

Month

17

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2013

Year

05

Month

17

Day

Last modified on

2015

Year

11

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012564