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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029992
Receipt No. 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 2019/07/01

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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
Email 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
Email tada.masafumi.76r@st.kyoto-u.ac.jp

Sponsor
Institute Kyoto university
Institute
Department

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
Email

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
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 Open public recruiting
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
2020 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information unpublished

Management information
Registered date
2017 Year 11 Month 15 Day
Last modified on
2019 Year 07 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033754

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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