UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the underlying mechanisms of remote ischemic preconditioningpreconditioning
Title of the study (Brief title)	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	Toru Miyoshi
Organization	Okayama University
Division name	Cardiovascular Medicine
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	Toru Miyoshi
Organization	Okayama University
Division name	Cardiovascular Medicine
Address	2-5-1 Shikada-cho Kita-ku Okayama
TEL	086-235-7351
Homepage URL
Email	miyoshit@cc.okayama-u.ac.jp

Sponsor
Institute	Okayama University, Department of Cardiovascular Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 06 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017666