Non ST Segment Elevation Myocardial Infarction Clinical Trial
Official title:
One-hour Diagnostic Algorithm for Non-ST Elevation Myocardial Infarction Based on Determination of Fatty-acid-binding Protein Concentration
Predictable values of the 1-hour algorithm for estimating the concentration of troponin using
highly sensitive reagents are 98-100% for excluding myocardial infarction (MI) and 75-80% for
identifying this pathology. Such algorithms are developed for the rapid confirmation or
exclusion of myocardial infarction without ST-segment elevation and, when combined with
clinical data and electrocardiogram, are used to assess the risk of adverse course of disease
and to contribute to decision making about expediency of stay in the intensive therapy unit
and early discharge.
In mid-1980s, a new marker of myocardial damage was proposed, namely: fatty-acid-binding
protein (FABP). However, the diagnostic value of FABP cannot be interpreted unambiguously
because of insufficient number of studies determining the sensitivity and specificity of the
test in various manifestations of acute coronary syndrome (ACS).
Available literature presents a wide range of reference values of FABP for MI diagnosis.
Reference value ranges are proposed by manufacturers of diagnostic kits based on previous
studies. In addition, there is no information about the FABP changes during the first three
hours of the disease, as well as there are no data on diagnostic value of changes in this
indicator ("∆") in patients with ACS without ST-segment elevation. These considerations
provide rationale and support novelty of the planned pilot study.
After enrollment in the study, patients will undergo the following procedures:
1. Physical examination (at baseline) and monitoring of vital signs (blood pressure, heart
rate, breathing rate) at hours 1, 2, and 3 after admission to hospital.
2. Registration of 12-lead electrocardiogram (ECG) (at baseline, after 24 hours, and at the
day of discharge).
3. At baseline (at the time of admission to hospital), venous blood will be obtained to
perform blood tests for determination of troponin I, FABP, and CPK-MB levels. At the
same time, venous blood will be sampled for routine clinical laboratory blood tests. At
hours 1, 2, and 3 after admission to hospital, venous blood will be sampled for
assessment of the troponin I and FABP levels.
4. Echocardiography will be performed 24 hours after admission (LVEDV, LVESV, and EF). At
day 3, standard echocardiography will be performed.
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