UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of myocardial protection by nicorandil during open-heart surgery under cardiopulmonary bypass
Title of the study (Brief title)	Myocardial protection by nicorandil
Region	Japan

Condition
Condition	valvular heart disease
Classification by specialty	Anesthesiology Cardiovascular surgery Operative medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	efficacy of myocardial protection by nicorandil during open-heart surgery under cardiopulmonary bypass
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Hemodynamics, markers for myocardial damage(CK-MB,TnT,H-FABP etc) at five time points(anesthesia induction, just, 1hr, 5hr and 24hr after cardiopulmonary bypass stopped).
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	aortic valve surgery transvenous administration of nicorandil (6mg/hr) for 24 hours.
Interventions/Control_2	aortic valve surgery control
Interventions/Control_3	cardiac valve surgery(except aortic valve), transvenous administration of nicorandil (6mg/hr) for 24 hours.
Interventions/Control_4	cardiac valve surgery(except aortic valve) control
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	elective heart valve replacement or plasty surgery
Key exclusion criteria	emergency surgery
Target sample size	60

Research contact person
Name of lead principal investigator	Sachiko Jomura
Organization	Kansai Medical University Hirakata hospital
Division name	Dept. Anesthesiology
Address	2-3-1 Shin-machi Hirakata-city Osaka
TEL
Email

Public contact
Name of contact person	Sachiko Jomura
Organization	Kansai Medical University Hirakata hospital
Division name	Dept. Anesthesiology
Address	2-3-1 Shin-machi Hirakata-city Osaka
TEL
Homepage URL
Email

Sponsor
Institute	Kansai Medical University, Dept. Anesthesiology
Institute
Department

Funding Source
Organization	Kansai Medical University, Dept. Anesthesiology
Organization
Division
Category of Funding Organization	Self funding
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	2011 Year 04 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 03 Month 31 Day
Anticipated trial start date	2011 Year 04 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	2011 Year 03 Month 16 Day
Last modified on	2018 Year 09 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006257