UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054014 |
|---|---|
| Receipt number | R000059374 |
| Scientific Title | Cohort Study for Patients with Acute Chest Pain |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2025/09/29 10:06:19 |
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Basic information
Public title
Cohort Study for Patients with Acute Chest Pain
Acronym
Cohort Study for Patients with Acute Chest Pain
Scientific Title
Cohort Study for Patients with Acute Chest Pain
Scientific Title:Acronym
Cohort Study for Patients with Acute Chest Pain
Region
| Japan |
Condition
Condition
acute coronary syndrome
Classification by specialty
| Medicine in general | Cardiology | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Validation of the utility of Heart Score for acute chest pain cases suspected of acute coronary syndrome
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
death or acute coronary syndrome within 30 days
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
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients presenting to the emergency department with acute chest pain and suspected acute coronary syndrome
Key exclusion criteria
age under 18 years old
obvious trauma
ST elevation acute myocardial infarction
shock
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Mamoru |
| Middle name | |
| Last name | Toyofuku |
Organization
Japanese Red Cross Wakayama Medical Center
Division name
Department of Cardiology
Zip code
640-8558
Address
4-20 Komatsubara-dori Wakayama City
TEL
073-422-4171
matoyofuku-circ@umin.ac.jp
Public contact
Name of contact person
| 1st name | Mamoru |
| Middle name | |
| Last name | Toyofuku |
Organization
Japanese Red Cross Wakayama Medical Center
Division name
Department of Cardiology
Zip code
640-8558
Address
4-20 Komatsubara-dori Wakayama City
TEL
073-422-4171
Homepage URL
matoyofuku-circ@umin.ac.jp
Sponsor or person
Institute
Japanese Red Cross Wakayama Medical Center
Institute
Department
Personal name
Funding Source
Organization
none
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
Ethics Comitree, Japanese Red Cross Wakayama Medical Center
Address
4-20 Komatsubara-dori Wakayama City
Tel
073-422-4171
0112sin@wakayama-med.jrc.or.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Circ Rep 2025; 7: 547-553 doi: 10.1253/circrep.CR-25-0060
Publication of results
Published
Result
URL related to results and publications
Circ Rep 2025; 7: 547-553 doi: 10.1253/circrep.CR-25-0060
Number of participants that the trial has enrolled
487
Results
This study analyzed 487 patients presenting with chest pain in our ED between April and December 2022. We enrolled patients with suspected ACS without ST-segment elevation and shock state. The primary outcome was MACE within 30 days following the ED visit. The endpoint occurred in 108 patients. The HEART score identified 140 (28%) low-risk patients with a HEART score under 3 who did not have any endpoint occurrence within 30 days. The AUC values of the HEART score for MACE was 0.87.
Results date posted
| 2025 | Year | 09 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This study analyzed 487 patients presenting with chest pain in our ED between April and December 2022. We enrolled patients with suspected ACS without ST segment elevation and shock state. The primary outcome was MACE within 30 days following the ED visit. The endpoint occurred in 108 patients. The HEART score identified 140 (28%) low-risk patients with a HEART score under 3 who did not have any endpoint occurrence within 30 days. The AUC values of the HEART score for MACE was 0.87.
Participant flow
This study enrolled 528 patients with suspected NSTEACS without shock state. After excluding 4 patients with duplicate enrollments and 37 patients who were lost to follow up at 30 days, the present study population comprised 487 patients.
Adverse events
This study is an observational study without intervention, and no adverse events have occurred.
Outcome measures
The primary outcome of MACE within 30 days occurred in 22.2% (108/487) of patients. Among the components of the primary composite outcome, death occurred in 14 patients, including 4 patients with MI and 3 patients who died within 30 days after coronary revascularization. MI occurred in 90 patients, in whom 70 patients underwent coronary revascularization (67 patients with percutaneous coronary intervention [PCI] and 5 patients with coronary artery bypass grafting [CABG]). Coronary revascularization was performed in 78 patients (PCI in 72 patients, CABG in 4 patients, and both in 2 patients; MI in 70 patients, and angina in 8 patients). The distribution of MI types was as follows: type 1 in 68 patients, type 2 in 13 patients, and MI with non-obstructive coronary artery (MINOCA)9 in 9 patients.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective single center registry of tertiary educational hospital to validate the Heart Pathway for the diagnosis and risk stratification of non-ST elevation acute coronary syndrome at emergency department(ED).
Measurements and end point; HEART score consists of five components of the history, electrocardiogram, age, risk factors, and troponin. Each component can be scored with zero, one or two points, depending on the extent of the abnormality. For patients with low risk heart score and negative troponin results including serial measurements, the HEART pathway recommends discharge from the ED without further testing. The endpoint was the composite of death, myocardial infarction, or coronary artery revascularization within 30 days.
Management information
Registered date
| 2024 | Year | 03 | Month | 30 | Day |
Last modified on
| 2025 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059374
