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One-hour Diagnostic Algorithm for NSTEMI

NCT03507270 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-03-07

No results posted yet for this study

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.

Conditions

  • Non ST Segment Elevation Myocardial Infarction

Interventions

DIAGNOSTIC_TEST

FABP

Assessment of changes in FABP concentrations

Sponsors & Collaborators

  • Tomsk National Research Medical Center of the Russian Academy of Sciences

    lead OTHER

Principal Investigators

  • Vyacheslav V. Ryabov, MD, PhD · Cardiology Research Institute, Tomsk NRMC

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-02
Primary Completion
2018-05-01
Completion
2018-10-01

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03507270 on ClinicalTrials.gov