UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034202
Receipt number R000038961
Scientific Title Predictors Developing Atrial Fibrillation during Thoracic Surgery
Date of disclosure of the study information 2018/09/20
Last modified on 2020/05/22 17:36:58

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Basic information

Public title

Predictors Developing Atrial Fibrillation during Thoracic Surgery

Acronym

Predictors Developing Atrial Fibrillation during Thoracic Surgery

Scientific Title

Predictors Developing Atrial Fibrillation during Thoracic Surgery

Scientific Title:Acronym

Predictors Developing Atrial Fibrillation during Thoracic Surgery

Region

Japan


Condition

Condition

Perioperative atrial fibrillation (AF)

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aims to investigate whether variations in pulse pressure after anesthetic induction are useful for predicting the development of AF during thoracoscopic esopahgectomy

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

The primary outcome was an intraoperative incidence of initial AF during the esophagectomy

Key secondary outcomes

Recurrent AF and major cardiovascular events within 30 postoperative days


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

40 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who underwent scheduled thoracoscopic esophagectomy in our institute from April 2008 to March 2013

Key exclusion criteria

Patients with history of sustained or paroxysmal AF and with cardiac comorbidity as potential AF cases, including congestive heart failure, more than moderate grade of valvular heart diseases, supraventricular arrhythmias, and anti-arrhythmic medication
Patients who changed scheduled procedures during his or her operation

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tokuhiro Yamada

Organization

Osaka City University Graduate School of Medicine

Division name

Anesthesiology

Zip code


Address

1-5-7 Asahimachi, Abeno, Osaka

TEL

+81-6-6645-2186

Email

tk078@med.osaka-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tokuhiro Yamada

Organization

Osaka City University Graduate School of Medicine

Division name

Anesthesiology

Zip code


Address

1-5-7 Asahimachi, Abeno, Osaka

TEL

+81-6-6645-2186

Homepage URL


Email

tk078@med.osaka-cu.ac.jp


Sponsor or person

Institute

Osaka City University

Institute

Department

Personal name



Funding Source

Organization

Nothing

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

2018 Year 09 Month 20 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

Completed

Date of protocol fixation

2013 Year 08 Month 05 Day

Date of IRB

2013 Year 08 Month 10 Day

Anticipated trial start date

2013 Year 08 Month 15 Day

Last follow-up date

2016 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The relationships between an intraoperative incidence of AF and the prognosis in 3 years of the postoperative period were additionally investigated.


Management information

Registered date

2018 Year 09 Month 19 Day

Last modified on

2020 Year 05 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038961


Research Plan
Registered date File name
2020/05/25 AF Data.xlsx

Research case data specifications
Registered date File name

Research case data
Registered date File name