UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020528
Receipt number R000023700
Scientific Title Evaluation of effect of remote ischemic peri-conditioning on the activation of sympathetic nervous system in patients with acute myocardial infarction
Date of disclosure of the study information 2016/01/12
Last modified on 2016/01/12 10:12:33

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Basic information

Public title

Evaluation of effect of remote ischemic peri-conditioning on the activation of sympathetic nervous system in patients with acute myocardial infarction

Acronym

Evaluation of effect of RIPC on the activation of sympathetic nervous system in patients with acute myocardial infarction

Scientific Title

Evaluation of effect of remote ischemic peri-conditioning on the activation of sympathetic nervous system in patients with acute myocardial infarction

Scientific Title:Acronym

Evaluation of effect of RIPC on the activation of sympathetic nervous system in patients with acute myocardial infarction

Region

Japan


Condition

Condition

Acute myocardial infarction

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of remote ischemic peri-conditioning on the sympathetic nerve activation in patients with acute myocardial infarction

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Late H/M ratio and washout rate of MIBG scintigraphy (planar image) at discharge

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

reperfusion therapy + remote ischemic peri-conditioning

Interventions/Control_2

reperfusion therapy

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

1 Patients with ST elevation myocardial infarction undergoing reperfusion therapy
2 Patients who received sufficient explanation, understood it and gave written consent based on their free will, before participating in this study

Key exclusion criteria

1 Patients with non-ST-elevation acute coronary syndrome
2 Patients who need percutaneous cardiopulmonary support
3 Patients who have difficulties to undergo the therapy, mentally or physically
4 Patients who are judged inappropriate by the principal investigator

Target sample size

162


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takumi Kondo

Organization

Osaka General Medical Center

Division name

Department of Cardiology

Zip code


Address

3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka

TEL

06-6692-1201

Email

kenkyusien@gh.opho.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takumi Kondo

Organization

Osaka General Medical Center

Division name

Department of Cardiology

Zip code


Address

3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka

TEL

06-6692-1201

Homepage URL


Email

kenkyusien@gh.opho.jp


Sponsor or person

Institute

Osaka General Medical Center

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


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

2016 Year 01 Month 12 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

Enrolling by invitation

Date of protocol fixation

2015 Year 08 Month 24 Day

Date of IRB


Anticipated trial start date

2016 Year 01 Month 12 Day

Last follow-up date

2019 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 01 Month 12 Day

Last modified on

2016 Year 01 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023700


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name