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COMPLETED
NCT03507270
NA

One-hour Diagnostic Algorithm for NSTEMI

Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences

View on ClinicalTrials.gov

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.

Official title: One-hour Diagnostic Algorithm for Non-ST Elevation Myocardial Infarction Based on Determination of Fatty-acid-binding Protein Concentration

Key Details

Gender

MALE

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2017-05-02

Completion Date

2018-10-01

Last Updated

2026-06-26

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

FABP

Assessment of changes in FABP concentrations

Locations (1)

Cardiology Research Institute, Tomsk NRMC

Tomsk, Russia