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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001915
Receipt No. R000002309
Scientific Title preventive effects of isosorbide dinitrate / nicorandil on myocardial ischemia during postoperative period in patients with coronary risk underwent non-cardiac surgeries
Date of disclosure of the study information 2009/05/21
Last modified on 2014/05/30

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Basic information
Public title preventive effects of isosorbide dinitrate / nicorandil on myocardial ischemia during postoperative period in patients with coronary risk underwent non-cardiac surgeries
Acronym preventive effects of isosorbide dinitrate / nicorandil on myocardial ischemia during postoperative period in patients underwent non-cardiac surgeries
Scientific Title preventive effects of isosorbide dinitrate / nicorandil on myocardial ischemia during postoperative period in patients with coronary risk underwent non-cardiac surgeries
Scientific Title:Acronym preventive effects of isosorbide dinitrate / nicorandil on myocardial ischemia during postoperative period in patients underwent non-cardiac surgeries
Region
Japan

Condition
Condition Postoperrative ischemic heart disease(postoperative)
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The risk of myocardial ischemia, arrhythmia during perioperative period increases in the patients with coronary risks such as hypertention, lipid metabolic disorder. Our purpose is to investigate the preventive effect of isosorbide dinitrate / nicorandil on myocardial ischemia during postoperative period in patients with coronary risk who are going under non-cardiac surgeries.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes myocardial ischemia(ECG),
arrhythmia, symptoms of heart failure, chest pain, heart attack
Key secondary outcomes adverse effect

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 non-treatment with vasodilators,
anti-anginal agents during staying
in intensive care unit
Interventions/Control_2 ISDN (0.5micro-g/kg/min)
Interventions/Control_3 nicorandil(0.6micro-g/kg/min)
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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients undergoing non-cardiac surgeries who are evaluated into classes of ASA 1/2 and have over 10 points of coronary risk index
Key exclusion criteria contraindication to medicines
treatment with beta blockers before surgery
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takuyo Misumi
Organization Kobe University Hospital
Division name Department of Intensive Care Unit
Zip code
Address 7-5-2,Kusunoki-cho,chuo-ku,kobe,Hyogo, 650-0017,Japan
TEL 078-382-5111
Email misumi@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Misumi Takuyo
Organization Kobe University Hospital
Division name Department of Intensive Care Unit
Zip code
Address 7-5-2,Kusunoki-cho,chuo-ku,kobe,Hyogo, 650-0017,Japan
TEL 078-382-5111
Homepage URL
Email misumi@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Graduate School of Medicine,
Division of Anesthesiology and Perioperative Medicine
Institute
Department

Funding Source
Organization Kobe University Graduate School of Medicine,
Division of Anesthesiology and Perioperative Medicine
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
2009 Year 05 Month 21 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 Terminated
Date of protocol fixation
2009 Year 04 Month 22 Day
Date of IRB
Anticipated trial start date
2009 Year 06 Month 01 Day
Last follow-up date
2014 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 04 Month 28 Day
Last modified on
2014 Year 05 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002309

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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