UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042322
Receipt number R000048311
Scientific Title Relationship between atrial fibrillation after coronary artery bypass graft and perioperative anesthesia Management
Date of disclosure of the study information 2020/11/03
Last modified on 2022/11/21 09:51:35

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Basic information

Public title

Relationship between atrial fibrillation after coronary artery bypass graft and
perioperative anesthesia Management

Acronym

Relationship between atrial fibrillation after coronary artery bypass graft and
perioperative anesthesia Management

Scientific Title

Relationship between atrial fibrillation after coronary artery bypass graft and
perioperative anesthesia Management

Scientific Title:Acronym

Relationship between atrial fibrillation after coronary artery bypass graft and
perioperative anesthesia Management

Region

Japan


Condition

Condition

Atrial fibrillation

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Examine the factors that contribute to the development of atrial fibrillation after coronary artery bypass surgery

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Occurrence of atrial fibrillation in the first 7 days after surgery

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who underwent coronary artery bypass surgery at Shiga University of Medical
Science Hospital between January 2010 and December 2019

Key exclusion criteria

Emergency surgery cases, patients with preoperative atrial fibrillation, dialysis patients

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Yasuhiko
Middle name
Last name Imashuku

Organization

Shiga University of Medical Science

Division name

Department of Anesthesiology

Zip code

5202192

Address

Seta Tsukinowa-cho, Otsu, Shiga, JAPAN

TEL

0775482281

Email

imashuku@belle.shiga-med.ac.jp


Public contact

Name of contact person

1st name Yasuhiko
Middle name
Last name Imashuku

Organization

Shiga University of Medical Science

Division name

Department of Anesthesiology

Zip code

5202192

Address

Seta Tsukinowa-cho, Otsu, Shiga, JAPAN

TEL

0775482281

Homepage URL


Email

imashuku@belle.shiga-med.ac.jp


Sponsor or person

Institute

Shiga University of Medical Science

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Shiga University of Medical Science Research Ethics Committee

Address

Seta Tsukinowa-cho, Otsu, Shiga, JAPAN

Tel

0775483576

Email

hqrec@belle.shiga-med.ac.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

滋賀医科大学医学部附属病院


Other administrative information

Date of disclosure of the study information

2020 Year 11 Month 03 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

No longer recruiting

Date of protocol fixation

2020 Year 01 Month 15 Day

Date of IRB

2020 Year 01 Month 15 Day

Anticipated trial start date

2021 Year 04 Month 01 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Retrospective study

Observation items
Background, Drug Data, Laboratory data
ECG data, Operation data


Management information

Registered date

2020 Year 11 Month 02 Day

Last modified on

2022 Year 11 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048311


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name