UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045934 |
|---|---|
| Receipt number | R000052433 |
| Scientific Title | The Comprehensive Registry on Symptom and Prognosis in Patients with Acute Coronary Syndrome |
| Date of disclosure of the study information | 2022/01/01 |
| Last modified on | 2024/04/02 15:18:01 |
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Basic information
Public title
The Comprehensive Registry on Symptom and Prognosis in Patients with Acute Coronary Syndrome
Acronym
Chest Patin Registry in Japana
Scientific Title
The Comprehensive Registry on Symptom and Prognosis in Patients with Acute Coronary Syndrome
Scientific Title:Acronym
Chest Patin Registry in Japan
Region
| Japan |
Condition
Condition
Patients who visited the emergency room with a chief complaint of chest symptoms and those diagnosed with acute coronary syndrome
Classification by specialty
| Medicine in general | Cardiology | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the nature of prodromal symptoms such as chest pain in patients who visited the emergency department with chest symptoms and those who were diagnosed with acute coronary syndrome. In addition, to clarify the diagnostic performance and prognostic performance of the symptoms for the acute coronary syndrome. By clarifying the nature of symptoms that are more specific to acute coronary syndrome, we may be able to contribute to improving the prognosis of acute coronary syndrome.
Basic objectives2
Others
Basic objectives -Others
If necessary, the details of the analysis should be described in the analysis plan.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The purpose of this study is to collect comprehensive data on patients with chest symptoms and acute coronary syndromes in order to establish a registry of acute coronary syndromes.
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
From the date of approval by the head of the research institution, we will enroll cases over the age of 18 that meet the following criteria A) and B) in Setting 1 and Setting 2, respectively, for a period of one year.
A) Setting 1: Cases presenting with chest pain (including typical symptoms of angina as well as other types of chest pain and discomfort) as the primary complaint at the ER of Rakuwakai Otowa Hospital.
B) Setting 2: Cases diagnosed with acute coronary syndrome (including acute myocardial infarction and unstable angina), even those presenting with cardiac arrest upon arrival.
Key exclusion criteria
1) Cases of onset within the hospital
2) Chest pain of obvious external origin
Rationale for Criteria: Patients who experienced onset within the hospital and those with chest pain of an external origin are not the focus of this study.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Taku |
| Middle name | |
| Last name | Iwami |
Organization
Kyoto University
Division name
Department of Preventive Services
Zip code
606-8501
Address
Yoshidahonmachi, Sakyo-ku, Kyoto city, Kyoto
TEL
075-753-2426
iwami.taku.8w@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Taku |
| Middle name | |
| Last name | Iwami |
Organization
Kyoto University
Division name
Department of Preventive Services
Zip code
606-8501
Address
Yoshidahonmachi, Sakyo-ku, Kyoto city, Kyoto
TEL
075-753-2426
Homepage URL
iwami.taku.8w@kyoto-u.ac.jp
Sponsor or person
Institute
Department of Preventive Services, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Japanese Circulation Society
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
Kyoto University
Address
Yoshidahonmachi, Sakyo-ku, Kyoto city, Kyoto
Tel
075-753-2387
810kikochosei@mail2.adm.kyoto-u.ac.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
| 2022 | Year | 01 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 02 | Month | 15 | Day |
Date trial data considered complete
| 2024 | Year | 02 | Month | 15 | Day |
Date analysis concluded
Other
Other related information
Measurement items
Medical information within the scope of normal practice will be collected from medical records and routine interviews. No new interventions or tests will be performed. For details, please refer to the attached data specification.
<Patient background and pre-hospital information
level, systolic blood pressure at the time of ambulance contact, diastolic blood pressure at the time of ambulance contact, pulse rate or heart rate at the time of ambulance contact, respiratory rate at the time of ambulance contact, SpO2% (room air) at the time of ambulance contact, place of living (home, medical facility, nursing home, other) before admission (onset), Barthel Index (on admission), etc.
<Item on chest symptoms
Date and time of first symptom onset, presence or absence of pre-infarction angina, mode of onset of chest pain, factors associated with remission and exacerbation, nature of chest symptoms, presence or absence of chest tenderness (pain to touch), location of pain, accompanying symptoms other than chest pain, duration of chest pain, frequency of attacks, diurnal variation, etc.
<Consultation and treatment
presence of shock, heart failure (Killip classification), use of assisted circulation, did the patient or family consider angina or myocardial infarction as a differential cause of the symptoms that led to the visit? Coronary angiography, presence of thrombotic occlusion on coronary angiography, presence of other stenosis/occlusion, estimated responsible lesion, concomitant stenosis (>75%), coronary angiography, reperfusion therapy (>75%) Coronary artery angiography, reperfusion therapy (coronary revascularization), if PCI, date and time of reperfusion (revascularization), if PCI, stenting, 12-lead ECG
<Outcome at discharge
Date of discharge, outcome at discharge, Barthel Index (at discharge), prescription at discharge
Management information
Registered date
| 2021 | Year | 10 | Month | 30 | Day |
Last modified on
| 2024 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052433
