UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012578
Receipt number R000014713
Scientific Title Effect of remote ischemic preconditioning on orgen protection in patients with ST-elevation myocardial infarction
Date of disclosure of the study information 2013/12/14
Last modified on 2015/01/15 09:58:30

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Basic information

Public title

Effect of remote ischemic preconditioning on orgen protection in patients with ST-elevation myocardial infarction

Acronym

RIPC-STEMI

Scientific Title

Effect of remote ischemic preconditioning on orgen protection in patients with ST-elevation myocardial infarction

Scientific Title:Acronym

RIPC-STEMI

Region

Japan


Condition

Condition

patients with ST-elevation myocardial infarction

Classification by specialty

Cardiology Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of remote ischemic preconditioning on organ damage in patients wiht ST-elevation myocardial infarction

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Incidence of contrast-induced nephropathy

Key secondary outcomes

Incidence of major adverse cardiac or cerebral event after PCI
Change in eGFR and infarct size


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -but assessor(s) are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Remote ischemic preconditioning

Interventions/Control_2

No treatment

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

(a)Patients who presented with chest pain within 24 hours of onset; had ST-segment elevation of > 0.1 mV in two contiguous leads in the first electrocardiogram recorded on the scene
(b)Age over 20 years old and sex is not asked
(c)Subjects who obtained written-informed consent for study participation

Key exclusion criteria

(a)Left bundle branch block
(b)Previous coronary bypass surgery
(c)Severe heart failure requiring percutaneous cardiopulmonary support
(d)Severe chronic kidney disease requiring dialysis or continuous hemodiafiltration
(e)Patinets whose biochemical ischemic markers failed to confirm a diagnosis of myocardial infarction
(f)Patients who are determined by the investigators to be unsuitable

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Ito

Organization

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Division name

Department of Cardiovascular Medicine

Zip code


Address

2-5-1, Shikata-cho, Kita-ku, Okayama

TEL

086-235-7351

Email

itomd@md.okayama-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toru Miyoshi

Organization

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Division name

Department of Cardiovascular Medicine

Zip code


Address

2-5-1, Shikata-cho, Kita-ku, Okayama

TEL

086-235-7351

Homepage URL


Email

miyoshit@cc.okayama-u.ac.jp


Sponsor or person

Institute

Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Institute

Department

Personal name



Funding Source

Organization

Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Organization

Division

Category of Funding Organization

Other

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 12 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

2013 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 07 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 12 Month 14 Day

Last modified on

2015 Year 01 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014713


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name