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The evaluation of the best diagnostic strategy to rule out non-ST elevation myocardial infarction in emergency rooms.

The evaluation of the best diagnostic strategy to rule out non-ST elevation myocardial infarction in emergency rooms. - The evaluation of the diagnostic strategy to rule-out myocardial infarction

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000029992
Enrollment
1500
Registered
2017-12-01
Start date
2018-07-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

myocardial infarction

Interventions

None listed

Sponsors

Kyoto university
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
*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.

Countries

Japan

Contacts

Public ContactMasafumi Tada

Kyoto university graduate school of medicine Department of health promotion and human behavior

tada.masafumi.76r@st.kyoto-u.ac.jp075-753-9491

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026