UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000034890
Receipt number R000039774
Scientific Title Early repolarization is a risk factor inducing lehtal ventiricluar arrhytymias during cardiac surgery.
Date of disclosure of the study information 2018/11/14
Last modified on 2019/10/21 15:12:41

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Basic information

Public title

Early repolarization is a risk factor inducing lehtal ventiricluar arrhytymias during cardiac surgery.

Acronym

Early repolarization and perioperative ventricular arrhythmias

Scientific Title

Early repolarization is a risk factor inducing lehtal ventiricluar arrhytymias during cardiac surgery.

Scientific Title:Acronym

Early repolarization and perioperative ventricular arrhythmias

Region

Japan


Condition

Condition

Heart diseases

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine whether early repolarizaion
produces lethal ventriclar arrhythmias
during a cardiac surgery

Basic objectives2

Others

Basic objectives -Others

None

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Frequency of lethal ventricular arrhythmias (ventriclar tachcardia and ventricular
fibliration)

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients undergoing a cardiac surgery

Key exclusion criteria

None

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Yukio
Middle name
Last name Hayashi

Organization

Sakurabashi-Watanabe Hospital

Division name

Anesthesiology

Zip code

530-0001

Address

2-4-32, Umeda, Kita-ku, Osaka, JAPAN

TEL

06-6341-8651

Email

yhayashi@anes.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name Yukio
Middle name
Last name Yukio

Organization

Sakurabashi-Watanabe Hospital

Division name

Anesthesiology

Zip code

530-0001

Address

2-4-32, Umeda, Kita-ku, Osaka, JAPAN

TEL

06-6341-8651

Homepage URL


Email

yhayashi@anes.med.osaka-u.ac.jp


Sponsor or person

Institute

Sakurabashi-Watanabe Hospital

Institute

Department

Personal name



Funding Source

Organization

Sakurabashi-Watanabe Hospital

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

Sakurabashi-Watanabe Hospital IRB

Address

2-432, Umeda, Kita-ku, Osaka, Japan

Tel

06-6341-8651

Email

i_oka@watanabe-hsp.or.jp


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

2018 Year 11 Month 14 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

Open public recruiting

Date of protocol fixation

2018 Year 10 Month 01 Day

Date of IRB

2018 Year 07 Month 20 Day

Anticipated trial start date

2018 Year 10 Month 01 Day

Last follow-up date

2020 Year 12 Month 20 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

None


Management information

Registered date

2018 Year 11 Month 14 Day

Last modified on

2019 Year 10 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039774


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name