UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015199
Receipt number R000017666
Scientific Title Evaluation of the underlying mechanisms of remote ischemic preconditioningpreconditioning
Date of disclosure of the study information 2014/09/17
Last modified on 2018/06/28 09:29:13

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Basic information

Public title

Evaluation of the underlying mechanisms of remote ischemic preconditioningpreconditioning

Acronym

Evaluation of the underlying mechanisms of remote ischemic preconditioning

Scientific Title

Evaluation of the underlying mechanisms of remote ischemic preconditioningpreconditioning

Scientific Title:Acronym

Evaluation of the underlying mechanisms of remote ischemic preconditioning

Region

Japan


Condition

Condition

Angina Pectoris

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of the underlying mechanisms of remote ischemic preconditioning

Basic objectives2

Others

Basic objectives -Others

Evaluation of the underlying mechanisms of remote ischemic preconditioning

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

(1) Measurements of Rho-associated kinases in leukocytes
(2)analysis exosomes after remote ischemic preconditioning

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Maneuver

Interventions/Control_1

Remote ischemic preconditioning

Interventions/Control_2


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

patients wiht effort angina pectoris or silent myocardial ischemia

Key exclusion criteria

(a) acute coronary syndrome
(b)sever liver/ kidney disease
(c)severe brain disorder
(d)severe hypotension or cardiogenic shock

Target sample size

32


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toru Miyoshi

Organization

Okayama University

Division name

Cardiovascular Medicine

Zip code


Address

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

TEL

086-235-7351

Email

miyoshit@cc.okayama-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toru Miyoshi

Organization

Okayama University

Division name

Cardiovascular Medicine

Zip code


Address

2-5-1 Shikada-cho Kita-ku Okayama

TEL

086-235-7351

Homepage URL


Email

miyoshit@cc.okayama-u.ac.jp


Sponsor or person

Institute

Okayama University, Department of Cardiovascular Medicine

Institute

Department

Personal name



Funding Source

Organization

Okayama University, Department of Cardiovascular Medicine

Organization

Division

Category of Funding Organization

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

2014 Year 09 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

Completed

Date of protocol fixation

2014 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2014 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

2014 Year 09 Month 17 Day

Last modified on

2018 Year 06 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017666


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name