The evaluation of the best diagnostic strategy to rule out non-ST elevation myocardial infarction in emergency rooms.
Not Applicable
- Conditions
- myocardial infarction
- Registration Number
- JPRN-UMIN000029992
- Lead Sponsor
- Kyoto university
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 1500
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method *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.