UMIN-CTR Clinical Trial

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

J wave syndromes

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Department of Anesthesiology, Kinki University Faculty of Medicine

Institute

Department

Personal name

Organization

Department of Anesthesiology, Kinki University Faculty of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

11

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

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