UMIN-ICDS Clinical Trial

Public title

JCS Chest Pain Registry

Acronym

JCS Chest Pain Registry

Scientific Title

JCS Chest Pain Registry

Scientific Title:Acronym

JCS Chest Pain Registry

Region

Japan

Condition

Patients presenting to the emergency department with chest pains and those diagnosed with acute coronary syndrome

Classification by specialty

Medicine in general	Cardiology	Emergency medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The objective of this study is to clarify the nature of symptoms, including chest pain, among patients who presented to the emergency department with chest symptoms and those diagnosed with acute coronary syndrome. By elucidating the specific characteristics of symptoms associated with acute coronary syndrome, there may be potential to contribute to the improvement of outcomes for acute coronary syndrome.

Basic objectives2

Others

Basic objectives -Others

Descriptive Study, Diagnostic Accuracy Study

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

1) Primary Outcome Measure
The presence or absence of a diagnosis of acute coronary syndrome

2) Secondary Outcome Measures
- Type of culprit lesion in acute coronary syndrome
- Presence or absence of in-hospital mortality
- Outcome at 30 days post-onset (including survival status)

Key secondary outcomes

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

Not applicable

Gender

Male and Female

Key inclusion criteria

In settings 1 and 2, register cases of individuals aged 18 and older that meet the following criteria A) and B), respectively:
A) Setting 1: Cases in which the primary complaint is chest pain (typical angina symptoms as well as other types of chest pain and chest discomfort) in patients who visited the ER of the collaborating research institution.
B) Setting 2: Cases diagnosed with acute coronary syndrome (including acute myocardial infarction and unstable angina) (cases of cardiac arrest upon arrival are also included).
*This includes chest pain and chest discomfort. However, cases with only dyspnea are excluded.
Rationale for setting: This is because the study targets adult patients (aged 18 and over) who visit the ER with chest pain, as well as patients with acute coronary syndrome.

Key exclusion criteria

Cases that meet any of the following criteria:
1. Cases where chest pain or acute coronary syndrome onset occurs within the hospital.
2. Cases of chest pain with a clear external cause.
3. Cases with only dyspnea (in the context of eligibility criterion A).

Target sample size

5746

Name of lead principal investigator

1st name	Taku
Middle name
Last name	Iwami

Organization

Kyoto University

Division name

Department of Preventive Services

Zip code

606-8315

Address

Yoshida-konoe cho, Sakyo Ward, Kyoto

TEL

075-753-4400

Email

iwami.taku.8w@kyoto-u.ac.jp

Name of contact person

1st name	Taku
Middle name
Last name	Iwami

Organization

Kyoto University

Division name

Department of Preventive Services

Zip code

606-8315

Address

Yoshida-konoe cho, Sakyo Ward, Kyoto

TEL

075-753-4400

Homepage URL

Email

iwami.taku.8w@kyoto-u.ac.jp

Institute

Kyoto University

Institute

Department

Personal name

Organization

The Japanese Circulation Society

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Kyoto University Graduate School and Faculty of Medicine, Ethics Committee

Address

Yoshida-Konoe-cho, Sakyo-ku, Kyoto

Tel

075-753-4642

Email

ethcom@kuhp.kyoto-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

洛和会音羽病院 (京都府)
獨協医科大学病院 (栃木県)
日本医科大学武蔵小杉病院 (東京都)
日本医科大学付属病院 (東京都)
国立病院機構大阪医療センター (大阪府)
東京女子医科大学 (東京都)
北海道医療センター (北海道)
順天堂大学医学部附属練馬病院/井上健司

Date of disclosure of the study information

2024

Year

04

Month

01

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

2024

Year

03

Month

27

Day

Date of IRB

Anticipated trial start date

2024

Year

04

Month

01

Day

Last follow-up date

2026

Year

05

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

1) Design: Prospective cohort study.
2) Methods:
Registration of Participants:
Information collected from patients medical records who meet all eligibility criteria will be entered into a dedicated database(TXP Medical EDC system).
3) Observation, Testing, Survey, and Reporting Items and Schedule:
a. Measurement items, methods, measurers, or measuring institutions:
Information obtained from regular medical practice, including medical records and daily inquiries, will be collected. Furthermore, in the context of Setting 1, to avoid information bias, information in the emergency department is primarily collected in the emergency department itself or entered based on medical records created in the emergency department. The entry of outcomes is conducted separately from this process.
The items to be collected are as follows: <Patient Background and Pre-Hospital Information>, <Items Related to Chest Symptoms>,
<Examination and Treatment Details>, <Blood Test Data at the Time of Consultation>, Outpatient high-sensitivity troponin values.
<Outcomes at the Time of Outpatient Visit> Prognosis in the emergency department (home discharge, hospital admission, outpatient death).
<Outcomes at Discharge> Date of discharge, outcome at discharge, Barthel Index at discharge, prescriptions at discharge.
<Outcomes at 30 Days After Onset> 30-day survival.

4) Analysis Overview:
a. Primary Outcome Measure: Presence of a diagnosis of acute coronary syndrome.
b. Secondary Outcome Measures: Type of lesion responsible for acute coronary syndrome, in-hospital death, outcome at 30 days post-onset (including death).
c. Main Analysis Methods: Descriptive statistical methods will summarize the data for each survey item. The relationship between the nature of chest pain and the diagnosis of acute coronary syndrome, responsible lesion, in-hospital death, and outcome at 30 days post-onset, as well as diagnostic performance, will be examined.

Registered date

2024

Year

03

Month

27

Day

Last modified on

2024

Year

03

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061617