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Completed
NCT03507270
One-hour Diagnostic Algorithm for NSTEMI
Conditions: Non ST Segment Elevation Myocardial Infarction
Sex: Male
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 20
Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
Location: Cardiology Research Institute, Tomsk NRMC Tomsk
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* Patients aged 18-80 years old
* Male patients
* Acute pain in the chest similar to myocardial infarction with/or without ECG changes
* Admission to the hospital within 4 hours from onset of the disease.
Exclusion Criteria:
* Patients with ACS in the preceding 30 days
* Cerebral blood circulation disorder
* Recent surgical intervention
* Extensive burns of degree 2-3
* Massive wounds and injuries
* Percutaneous coronary intervention or cardioversion
* Pregnancy or lactation
* Malignant tumors of stage 4
* Severe renal insufficiency (GFR\< 30 mL/min)
Source: ClinicalTrials.gov (NCT03507270). StuddyBuddy aggregates publicly available trial information.