UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029992 |
|---|---|
| Receipt number | R000033754 |
| Scientific Title | The evaluation of the best diagnostic strategy to rule out non-ST elevation myocardial infarction in emergency rooms. |
| Date of disclosure of the study information | 2017/12/01 |
| Last modified on | 2023/05/21 09:32:07 |
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Basic information
Public title
The evaluation of the best diagnostic strategy to rule out non-ST elevation myocardial infarction in emergency rooms.
Acronym
The evaluation of the diagnostic strategy to rule-out myocardial infarction
Scientific Title
The evaluation of the best diagnostic strategy to rule out non-ST elevation myocardial infarction in emergency rooms.
Scientific Title:Acronym
The evaluation of the diagnostic strategy to rule-out myocardial infarction
Region
| Japan |
Condition
Condition
myocardial infarction
Classification by specialty
| Cardiology | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the diagnostic accuracy of non-structured models; which is comprised of risk estimation
of history and physical findings in a non-structured way; ECG; troponin; for the composite outcome of myocardial infarction and death within 30 days. Model 1 uses troponin value on arrival. Model 2 uses troponin values on arrival and after 1 hour. Model 3
uses troponin values on arrival and after 2 hours.
Basic objectives2
Others
Basic objectives -Others
We compare the diagnostic accuracy of non-structured models and structured models (existing prediction rules).
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcomes are the diagnostic accuracy of three non-structured models for composite of myocardial infarction and death within 30 days. The measures of accuracy are; negative predictive value; sensitivity; percentages of patients eligible for rule-out of myocardial infarction. The non-structured models are comprised of three elements and judged as positive if at least one of the elements is positive. 3 non-structured models are below.
*Model 1
1: history and physical findings are high risk
2: presence of new ischemic changes of ECG
3: troponin on arrival is positive
*Model2
1: history and physical findings are high risk
2: presence of new ischemic changes of ECG
3: troponin on arrival and/or after one hour is
positive
*Model 3
1: history and physical findings are high risk
2: presence of new ischemic changes of ECG
3: troponin on arrival and/or after 2 hours is
positive
Key secondary outcomes
*Secondary outcome 1
Comparison of the diagnostic accuracy of non-structured models and structured models
*Secondary outcome 2
We separate patients by some factors, such as onset to arrival time; presence or absence of chest pain; past history of myocardial infarction; past history
of coronary artery disease.
*Secondary outcome 3
Reliabilities of the risk estimation of history and physical findings in a non-structured way; each component of history and physical findings; ECG.
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
| 25 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Age: =>25 year old
2) Symptoms suggesting myocardial infarction
1. chest pain
2. non-chest pain
A. radiation pain
B. syncope
C. dyspnea
D. nausea
E. fatigue
F. symptoms which emergency physician judges
to rule out myocardial infarction
3) Symptom onset is within 6 hours
4) No ST elevation at presentation
5) Emergency physician judges to take both ECG
and troponin to rule out myocardial infarction
Key exclusion criteria
Satisfies any of the below
1) Cardiopulmonary arrest on arrival
2) Non-cardiac terminal illness
3) Shock status
4) Indication of immediate coronary angiography
5) Inability to obtain informed consent
6) History of severe trauma
7) Past registration for this study
8) Inability of telephone follow up
9) Unknown onset time
10) Judged as inappropriate by a board certified
emergency physician
11) Respiratory failure
12) Apparent need to admit for a diagnosis other than ACS
13) Patients on maintenance dialysis
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masafumi Tada |
Organization
Kyoto university graduate school of medicine
Division name
Department of health promotion and human behavior
Zip code
Address
Konoe-cho, Sakyo-ku, Kyoto
TEL
075-753-9491
tada.masafumi.76r@st.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masafumi Tada |
Organization
Kyoto university graduate school of medicine
Division name
Department of health promotion and human behavior
Zip code
Address
Konoe-cho, Sakyo-ku, Kyoto
TEL
075-753-9491
Homepage URL
tada.masafumi.76r@st.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto university
Institute
Department
Personal name
Funding Source
Organization
Nakatani foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
https://bmjopen.bmj.com/content/9/9/e026985.abstract
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
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
unpublished
Management information
Registered date
| 2017 | Year | 11 | Month | 15 | Day |
Last modified on
| 2023 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033754
