UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001915
Receipt number 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 15:42:24

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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 or person

Institute

Kobe University Graduate School of Medicine,
Division of Anesthesiology and Perioperative Medicine

Institute

Department

Personal name



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

Value
https://center6.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