UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012300
Receipt number R000013795
Scientific Title Preoperative prevalence of electrocardiographic patterns of J wave syndromes and the incidence of perioperative cardiac events in a patient with them
Date of disclosure of the study information 2013/11/20
Last modified on 2013/11/14 21:05:34

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Basic information

Public title

Preoperative prevalence of electrocardiographic patterns of J wave syndromes
and the incidence of perioperative cardiac events in a patient with them

Acronym

Preoperative prevalence of electrocardiographic patterns of J wave syndromes
and the incidence of perioperative cardiac events in a patient with them

Scientific Title

Preoperative prevalence of electrocardiographic patterns of J wave syndromes
and the incidence of perioperative cardiac events in a patient with them

Scientific Title:Acronym

Preoperative prevalence of electrocardiographic patterns of J wave syndromes
and the incidence of perioperative cardiac events in a patient with them

Region

Japan


Condition

Condition

J wave syndromes

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In the present study, we
examined the prevalence of each type ofJ wave syndromes and investigated its cardiac incidents during and after anesthesia.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Preoperative prevalence of electrocardiographic patterns of J wave syndromes

Key secondary outcomes

Perioperative cardiac incidents
were examined up to 1 year after the surgery.


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

18 years-old <

Age-upper limit

100 years-old >

Gender

Male and Female

Key inclusion criteria

More than 17 years old who were scheduled to surgery were investigated retrospectively.
Patients for cardiac surgery or who were already diagnosed as Brugada syndrome were excluded. ER was defined as 0.1mV or more ST elevation at the J point in more than one lead of 12-lead ECG and the J wave was defined as upward deflection as slurring or notching terminal part of QRS complex.
ECG patterns of J wave syndromes were classified as follows:
type 1 ,an ER pattern with J waves in lateral leads(I,V4-5) which is commonly seen in
healthy people,type2,an ER pattern with J waves in inferior leads (II,III,aVF) which is associated with a higher level of risk for VF, type3, an ER pattern with J waves in global leads which is associated with the highest level of risk for VF, and Brugada
syndrome pattern, an ER pattern with J waves in V1-3. Perioperative cardiac incidents were examined up to 1 year after the surgery.

Key exclusion criteria

1) those with obvious heart disease, a serious arrhythmia
2) less than 18 years old
3) emergency surgery
4)Patients who were confirmed dead within a year

Target sample size

10000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masaki Fuyuta

Organization

Kinki University Faculty of Medicine

Division name

Department of Anesthesiology

Zip code


Address

377-2, Ohno-Higashi, OsakaSayama,

TEL

072-366-0221

Email

mf29022902@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masaki Fuyuta

Organization

Kinki University Faculty of Medicine

Division name

Department of Anesthesiology

Zip code


Address

377-2, Ohno-Higashi, OsakaSayama,

TEL

072-366-0221

Homepage URL


Email

mf29022902@yahoo.co.jp


Sponsor or person

Institute

Department of Anesthesiology, Kinki University Faculty of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Anesthesiology, Kinki University Faculty of 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

2013 Year 11 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

Preinitiation

Date of protocol fixation

2013 Year 09 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 11 Month 20 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

More than 17 years old who were scheduled to surgery were investigated retrospectively.
Patients for cardiac surgery or who were already diagnosed as Brugada syndrome were excluded. ER was defined as 0.1mV or more ST elevation at the J point in more than one lead of 12-lead ECG and the J wave was defined as upward deflection as slurring or notching terminal part of QRS complex.
ECG patterns of J wave syndromes were classified as follows:
type 1 ,an ER pattern with J waves in lateral leads(I,V4-5) which is commonly seen in
healthy people,type2,an ER pattern with J waves in inferior leads (II,III,aVF) which is associated with a higher level of risk for VF, type3, an ER pattern with J waves in global leads which is associated with the highest level of risk for VF, and Brugada
syndrome pattern, an ER pattern with J waves in V1-3. Perioperative cardiac incidents were examined up to 1 year after the surgery.


Management information

Registered date

2013 Year 11 Month 14 Day

Last modified on

2013 Year 11 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013795


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name